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| ID | Type | Description | Link |
|---|---|---|---|
| RESIST 2 |
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The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tipranavir(TPV)/low dose ritonavir(r) | Other |
| |
| Comparator protease inhibitor(CPI)/low dose ritonavir(r) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tipranavir (with low dose ritonavir) | Drug |
| ||
| Comparator protease inhibitor(CPI)/low dose ritonavir(r) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response at Week 48 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | after 48 weeks of treatment |
| Time to Treatment Failure Through 48 Weeks of Treatment | Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1. | after 48 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response at Week 2 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 2 |
| Treatment Response at Week 4 |
Not provided
Inclusion Criteria:
Signed informed consent prior to trial participation.
Human immunodeficiency virus-1 infected males or females >=18 years of age.
Screening genotypic resistance report indicating both of the following:
At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,
Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening.
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).
Exclusion Criteria:
Antiretroviral medication naïve.
Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit.
Female patients of child-bearing potential who:
Prior tipranavir use.
Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1182.48.5401 Fundación Huésped | Buenos Aires | Argentina | ||||
| 1182.48.5402 Fundación Huésped |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20003457 | Derived | Mikl J, Sulkowski MS, Benhamou Y, Dieterich D, Pol S, Rockstroh J, Robinson PA, Ranga M, Stern JO. Hepatic profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009 Dec 14;9:203. doi: 10.1186/1471-2334-9-203. | |
| 16890833 | Derived | Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75. doi: 10.1016/S0140-6736(06)69154-X. |
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The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | |
| FG001 | Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound |
| week 4 |
| Treatment Response at Week 8 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 8 |
| Treatment Response at Week 16 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 16 |
| Treatment Response at Week 24 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Week 24 |
| Treatment Response at Week 32 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 32 |
| Treatment Response at Week 40 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 40 |
| Treatment Response at Week 56 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 56 |
| Treatment Response at Week 64 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 64 |
| Treatment Response at Week 72 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 72 |
| Treatment Response at Week 80 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 80 |
| Treatment Response at Week 88 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | week 88 |
| Treatment Response at Week 96 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | after 96 weeks of treatment |
| Time to Treatment Failure Through 96 Weeks of Treatment | Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1. | after 96 weeks of treatment |
| Time to Confirmed Virologic Failure Through 48 Weeks of Treatment | Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1. | after 48 weeks of treatment |
| Time to Confirmed Virologic Failure Through 96 Weeks of Treatment | Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1. | after 96 weeks of treatment |
| Virologic Response | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Week 2 through Week 96 (at any point during trial) |
| Virologic Response at Week 2 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Week 2 |
| Virologic Response at Week 4 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 4 |
| Virologic Response at Week 8 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 8 |
| Virologic Response at Week 16 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 16 |
| Virologic Response at Week 24 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 24 |
| Virologic Response at Week 32 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 32 |
| Virologic Response at Week 40 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 40 |
| Virologic Response at Week 48 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 48 |
| Virologic Response at Week 56 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 56 |
| Virologic Response at Week 64 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | week 64 |
| Virologic Response at Week 72 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Week 72 |
| Virologic Response at Week 80 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Week 80 |
| Virologic Response at Week 88 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Week 88 |
| Virologic Response at Week 96 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Week 96 |
| Median Change From Baseline in Viral Load (Week 2) | Baseline to Week 2 |
| Median Change From Baseline in Viral Load (Week 4) | Baseline to Week 4 |
| Median Change From Baseline in Viral Load (Week 8) | Baseline to Week 8 |
| Median Change From Baseline in Viral Load (Week 16) | Baseline to Week 16 |
| Median Change From Baseline in Viral Load (Week 24) | Baseline to Week 24 |
| Median Change From Baseline in Viral Load (Week 32) | Baseline to Week 32 |
| Median Change From Baseline in Viral Load (Week 40) | Baseline to Week 40 |
| Median Change From Baseline in Viral Load (Week 48) | Baseline to Week 48 |
| Median Change From Baseline in Viral Load (Week 56) | Baseline to Week 56 |
| Median Change From Baseline in Viral Load (Week 64) | Baseline to Week 64 |
| Median Change From Baseline in Viral Load (Week 72) | Baseline to Week 72 |
| Median Change From Baseline in Viral Load (Week 80) | Baseline to Week 80 |
| Median Change From Baseline in Viral Load (Week 88) | Baseline to Week 88 |
| Median Change From Baseline in Viral Load (Week 96) | Baseline to Week 96 |
| Virologic Response at Week 40 | Virologic response defined as Viral Load<400 copies/mL | Week 40 |
| Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks | Virologic response defined as Viral Load<400 copies/mL | Week 2 through Week 96 (at any point during trial) |
| Virologic Response at Week 2 | Virologic response defined as Viral Load<400 copies/mL | Week 2 |
| Virologic Response at Week 4 | Virologic response defined as Viral Load<400 copies/mL | Week 4 |
| Virologic Response at Week 8 | Virologic response defined as Viral Load<400 copies/mL | Week 8 |
| Virologic Response at Week 16 | Virologic response defined as Viral Load<400 copies/mL | Week 16 |
| Virologic Response at Week 24 | Virologic response defined as Viral Load<400 copies/mL | Week 24 |
| Virologic Response at Week 32 | Virologic response defined as Viral Load<400 copies/mL | Week 32 |
| Virologic Response at Week 48 | Virologic response defined as Viral Load<400 copies/mL | Week 48 |
| Virologic Response at Week 56 | Virologic response defined as Viral Load<400 copies/mL | Week 56 |
| Virologic Response at Week 64 | Virologic response defined as Viral Load<400 copies/mL | Week 64 |
| Virologic Response at Week 72 | Virologic response defined as Viral Load<400 copies/mL | Week 72 |
| Virologic Response at Week 80 | Virologic response defined as Viral Load<400 copies/mL | Week 80 |
| Virologic Response at Week 88 | Virologic response defined as Viral Load<400 copies/mL | week 88 |
| Virologic Response at Week 96 | Virologic response defined as Viral Load<400 copies/mL | week 96 |
| Virologic Response | Virologic response defined as Viral Load<50 copies/mL | Week 2 through Week 96 (at any point during trial) |
| Virologic Response at Week 2 | Virologic response defined as Viral Load<50 copies/mL | Week 2 |
| Virologic Response at Week 4 | Virologic response defined as Viral Load<50 copies/mL | Week 4 |
| Virologic Response at Week 8 | Virologic response defined as Viral Load<50 copies/mL | Week 8 |
| Virologic Response at Week 16 | Virologic response defined as Viral Load<50 copies/mL | Week 16 |
| Virologic Response at Week 24 | Viral Load < 50 copies/mL | Week 24 |
| Virologic Response at Week 32 | Virologic response defined as Viral Load<50 copies/mL | Week 32 |
| Virologic Response at Week 40 | Virologic response defined as Viral Load<50 copies/mL | Week 40 |
| Virologic Response at Week 48 | Virologic response defined as Viral Load<50 copies/mL | Week 48 |
| Virologic Response at Week 56 | Virologic response defined as Viral Load<50 copies/mL | Week 56 |
| Virologic Response at Week 64 | Virologic response defined as Viral Load<50 copies/mL | Week 64 |
| Virologic Response at Week 72 | Virologic response defined as Viral Load<50 copies/mL | Week 72 |
| Virologic Response at Week 80 | Virologic response defined as Viral Load<50 copies/mL | Week 80 |
| Virologic Response at Week 88 | Virologic response defined as Viral Load<50 copies/mL | Week 88 |
| Virologic Response at Week 96 | Virologic response defined as Viral Load<50 copies/mL | Week 96 |
| Mean Change From Baseline in CD4+ Cell Count (Week 2) | Baseline to Week 2 |
| Mean Change From Baseline in CD4+ Cell Count (Week 4) | Baseline to Week 4 |
| Mean Change From Baseline in CD4+ Cell Count (Week 8) | Baseline to Week 8 |
| Mean Change From Baseline in CD4+ Cell Count (Week 16) | Baseline to Week 16 |
| Mean Change From Baseline in CD4+ Cell Count (Week 24) | Baseline to Week 24 |
| Mean Change From Baseline in CD4+ Cell Count (Week 32) | Baseline to Week 32 |
| Mean Change From Baseline in CD4+ Cell Count (Week 40) | Baseline to Week 40 |
| Mean Change From Baseline in CD4+ Cell Count (Week 48) | Baseline to Week 48 |
| Mean Change From Baseline in CD4+ Cell Count (Week 56) | Baseline to Week 56 |
| Mean Change From Baseline in CD4+ Cell Count (Week 64) | Baseline to Week 64 |
| Mean Change From Baseline in CD4+ Cell Count (Week 72) | Baseline to Week 72 |
| Mean Change From Baseline in CD4+ Cell Count (Week 80) | Baseline to Week 80 |
| Mean Change From Baseline in CD4+ Cell Count (Week 88) | Baseline to Week 88 |
| Mean Change From Baseline in CD4+ Cell Count (Week 96) | Baseline to Week 96 |
| Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. | Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition. The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time. | up to 75 weeks of treatment |
| Buenos Aires |
| Argentina |
| 1182.48.5403 Servicio de Infecciosas | Buenos Aires | Argentina |
| 1182.48.5404 Servicio de Infecciosas | Buenos Aires | Argentina |
| 1182.48.5405 Hospital Muniz | Buenos Aires | Argentina |
| 1182.48.5406 Servicio de Immunocomprometido | Buenos Aires | Argentina |
| 1182.48.4301 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1182.48.3209 Boehringer Ingelheim Investigational Site | Antwerp | Belgium |
| 1182.48.3201 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1182.48.3202 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1182.48.3206 Boehringer Ingelheim Investigational Site | Charleroi | Belgium |
| 1182.48.3207 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| 1182.48.3210 Boehringer Ingelheim Investigational Site | Luxembourg | Belgium |
| 1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM | Campinas - SP | Brazil |
| 1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC | Curitiba - PR | Brazil |
| 1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde | Nova Iguaçu - RJ | Brazil |
| 1182.48.5502 Fundação Oswaldo Cruz | Rio de Janeiro - RJ | Brazil |
| 1182.48.5509 Universidade Federal do Rio de Janeiro | Rio de Janeiro - RJ | Brazil |
| 1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d | Salvador - BA | Brazil |
| 1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia | São Paulo - SP | Brazil |
| 1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas | São Paulo - SP | Brazil |
| 1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE | São Paulo - SP | Brazil |
| 1182.48.5506 Centro de Referência e Treinamento - DST/AIDS | São Paulo - SP | Brazil |
| 1182.48.5508 I.I. Emilio Ribas | São Paulo - SP | Brazil |
| 1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo | São Paulo - SP | Brazil |
| 1182.48.5513 UNIFESP - Centro de Pesquisa Clinica | São Paulo - SP | Brazil |
| 1182.48.4505 Boehringer Ingelheim Investigational Site | Aarhus N | Denmark |
| 1182.48.4502 Boehringer Ingelheim Investigational Site | Hvidovre | Denmark |
| 1182.48.4501 Boehringer Ingelheim Investigational Site | København Ø | Denmark |
| 1182.48.4504 Boehringer Ingelheim Investigational Site | Odense C | Denmark |
| 1182.48.3311 Boehringer Ingelheim Investigational Site | Besançon | France |
| 1182.48.3307 Boehringer Ingelheim Investigational Site | Bordeaux | France |
| 1182.48.3317 Boehringer Ingelheim Investigational Site | Bordeaux | France |
| 1182.48.3302 Boehringer Ingelheim Investigational Site | Caen | France |
| 1182.48.3303 Boehringer Ingelheim Investigational Site | Clamart | France |
| 1182.48.3305 Boehringer Ingelheim Investigational Site | Le Kremlin-Bicêtre | France |
| 1182.48.3304 Boehringer Ingelheim Investigational Site | Lyon | France |
| 1182.48.3322 Boehringer Ingelheim Investigational Site | Lyon | France |
| 1182.48.3308 Boehringer Ingelheim Investigational Site | Marseille | France |
| 1182.48.3309 Boehringer Ingelheim Investigational Site | Marseille | France |
| 1182.48.3318 Boehringer Ingelheim Investigational Site | Nantes | France |
| 1182.48.3306 Boehringer Ingelheim Investigational Site | Nice | France |
| 1182.48.3301 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3310 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3312 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3316 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3319 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3321 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3323 Boehringer Ingelheim Investigational Site | Paris | France |
| 1182.48.3315 Boehringer Ingelheim Investigational Site | Rennes | France |
| 1182.48.3313 Boehringer Ingelheim Investigational Site | Strasbourg | France |
| 1182.48.3314 Boehringer Ingelheim Investigational Site | Vandœuvre-lès-Nancy | France |
| 1182.48.3320 Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1182.48.4911 Boehringer Ingelheim Investigational Site | Aachen | Germany |
| 1182.48.4901 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1182.48.4902 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1182.48.4903 Boehringer Ingelheim Investigational Site | Bochum | Germany |
| 1182.48.4918 Boehringer Ingelheim Investigational Site | Bonn | Germany |
| 1182.48.4905 Boehringer Ingelheim Investigational Site | Cologne | Germany |
| 1182.48.4926 Boehringer Ingelheim Investigational Site | Cologne | Germany |
| 1182.48.4906 Boehringer Ingelheim Investigational Site | Dortmund | Germany |
| 1182.48.4912 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1182.48.4914 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1182.48.4908 Boehringer Ingelheim Investigational Site | Erlangen | Germany |
| 1182.48.4904 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1182.48.4924 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany |
| 1182.48.4928 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1182.48.4930 Boehringer Ingelheim Investigational Site | Freiburg/Breisgau | Germany |
| 1182.48.4916 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1182.48.4929 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1182.48.4931 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1182.48.4913 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1182.48.4920 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1182.48.4909 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1182.48.4923 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
| 1182.48.4907 Boehringer Ingelheim Investigational Site | München | Germany |
| 1182.48.4910 Boehringer Ingelheim Investigational Site | München | Germany |
| 1182.48.4915 Boehringer Ingelheim Investigational Site | Osnabrück | Germany |
| 1182.48.4919 Boehringer Ingelheim Investigational Site | Regensburg | Germany |
| 1182.48.4921 Boehringer Ingelheim Investigational Site | Stuttgart | Germany |
| 1182.48.4927 Boehringer Ingelheim Investigational Site | Stuttgart | Germany |
| 1182.48.3001 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1182.48.3002 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1182.48.3003 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1182.48.3004 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1182.48.3006 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1182.48.3007 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1182.48.3005 Boehringer Ingelheim Investigational Site | Goudi, Athens | Greece |
| 1182.48.3010 Boehringer Ingelheim Investigational Site | Pátrai | Greece |
| 1182.48.3008 Boehringer Ingelheim Investigational Site | Peraeus | Greece |
| 1182.48.3009 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1182.48.3531 Boehringer Ingelheim Investigational Site | Dublin | Ireland |
| 1182.48.3930 Boehringer Ingelheim Investigational Site | Ancona | Italy |
| 1182.48.3920 Boehringer Ingelheim Investigational Site | Antella (fi) | Italy |
| 1182.48.3926 Boehringer Ingelheim Investigational Site | Bari | Italy |
| 1182.48.3932 Boehringer Ingelheim Investigational Site | Bergamo | Italy |
| 1182.48.3908 Boehringer Ingelheim Investigational Site | Brescia | Italy |
| 1182.48.3929 Boehringer Ingelheim Investigational Site | Busto Arsizio (va) | Italy |
| 1182.48.3917 Boehringer Ingelheim Investigational Site | Ferrara | Italy |
| 1182.48.3919 Boehringer Ingelheim Investigational Site | Florence | Italy |
| 1182.48.3905 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1182.48.3927 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1182.48.3925 Boehringer Ingelheim Investigational Site | Lecco | Italy |
| 1182.48.3901 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1182.48.3907 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1182.48.3924 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1182.48.3934 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1182.48.3915 Boehringer Ingelheim Investigational Site | Modena | Italy |
| 1182.48.3912 Boehringer Ingelheim Investigational Site | Naples | Italy |
| 1182.48.3921 Boehringer Ingelheim Investigational Site | Padova | Italy |
| 1182.48.3916 Boehringer Ingelheim Investigational Site | Pavia | Italy |
| 1182.48.3922 Boehringer Ingelheim Investigational Site | Pavia | Italy |
| 1182.48.3910 Boehringer Ingelheim Investigational Site | Province of Macerata | Italy |
| 1182.48.3904 Boehringer Ingelheim Investigational Site | Rimini | Italy |
| 1182.48.3902 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1182.48.3903 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1182.48.3909 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1182.48.3935 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1182.48.3906 Boehringer Ingelheim Investigational Site | Torino | Italy |
| 1182.48.3914 Boehringer Ingelheim Investigational Site | Torino | Italy |
| 1182.48.3931 Boehringer Ingelheim Investigational Site | Torino | Italy |
| 1182.48.3933 Boehringer Ingelheim Investigational Site | Treviso | Italy |
| 1182.48.5201 Centro Médico La Raza IMSS | Mexico City | Mexico |
| 1182.48.5202 Hospital Lopez Mateos | México | Mexico |
| 1182.48.5203 Centro Guadalajara, Jal. | México | Mexico |
| 1182.48.5206 Centro Medico San Vicente | Monterrey, N.l. | Mexico |
| 1182.48.3101 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1182.48.3106 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1182.48.3108 Boehringer Ingelheim Investigational Site | Groningen | Netherlands |
| 1182.48.3105 Boehringer Ingelheim Investigational Site | Nijmegen | Netherlands |
| 1182.48.3104 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands |
| 1182.48.3110 Boehringer Ingelheim Investigational Site | The Hague | Netherlands |
| 1182.48.3502 Boehringer Ingelheim Investigational Site | Cascais | Portugal |
| 1182.48.3503 Boehringer Ingelheim Investigational Site | Coimbra | Portugal |
| 1182.48.3501 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1182.48.3505 Hospital Egas Moniz | Lisbon | Portugal |
| 1182.48.3504 Hospital de São João | Porto | Portugal |
| 1182.48.3415 Boehringer Ingelheim Investigational Site | Alicante | Spain |
| 1182.48.3405 Boehringer Ingelheim Investigational Site | Badalona | Spain |
| 1182.48.3401 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1182.48.3407 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1182.48.3408 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1182.48.3409 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1182.48.3416 Boehringer Ingelheim Investigational Site | Donostia / San Sebastian | Spain |
| 1182.48.3406 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain |
| 1182.48.3402 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1182.48.3403 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1182.48.3404 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1182.48.3410 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1182.48.3411 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1182.48.3412 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1182.48.3417 Boehringer Ingelheim Investigational Site | Málaga | Spain |
| 1182.48.3413 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1182.48.3414 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| 1182.48.3420 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| 1182.48.3418 Boehringer Ingelheim Investigational Site | Vigo | Spain |
| 1182.48.4603 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1182.48.4602 Boehringer Ingelheim Investigational Site | Malmö | Sweden |
| 1182.48.4601 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| 1182.48.4101 Universitätsspital Basel | Basel | Switzerland |
| 1182.48.4104 Hopital Universitaire de Genève | Geneva | Switzerland |
| 1182.48.4103 Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| 1182.48.4102 Universitätsspital Zürich | Zurich | Switzerland |
| 1182.48.4405 Boehringer Ingelheim Investigational Site | Brighton | United Kingdom |
| 1182.48.4412 Boehringer Ingelheim Investigational Site | Edinburgh | United Kingdom |
| 1182.48.4411 Boehringer Ingelheim Investigational Site | Liverpool | United Kingdom |
| 1182.48.4404 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1182.48.4406 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1182.48.4408 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1182.48.4409 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1182.48.4414 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1182.48.4418 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1182.48.4417 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | United Kingdom |
| 1182.48.4407 Boehringer Ingelheim Investigational Site | Portsmouth | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | |
| BG001 | Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis. | Count of Participants | Participants |
|
| 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 | Treatment Response at Week 48 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | after 48 weeks of treatment |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Treatment Failure Through 48 Weeks of Treatment | Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1. | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Days | after 48 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 2 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 2 |
|
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| Secondary | Treatment Response at Week 4 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 8 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 8 |
|
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| Secondary | Treatment Response at Week 16 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 24 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 32 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 32 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 40 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 40 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 56 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 64 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 64 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 72 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 72 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 80 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 80 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 88 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | week 88 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response at Week 96 | Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | percentage of participants | after 96 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure Through 96 Weeks of Treatment | Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1. | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Days | after 96 weeks of treatment |
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| Secondary | Time to Confirmed Virologic Failure Through 48 Weeks of Treatment | Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1. | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Days | after 48 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Confirmed Virologic Failure Through 96 Weeks of Treatment | Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1. | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Days | after 96 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 2 through Week 96 (at any point during trial) |
|
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| Secondary | Virologic Response at Week 2 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 2 |
|
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| Secondary | Virologic Response at Week 4 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 4 |
|
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| Secondary | Virologic Response at Week 8 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 8 |
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| Secondary | Virologic Response at Week 16 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 16 |
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| Secondary | Virologic Response at Week 24 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 24 |
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| Secondary | Virologic Response at Week 32 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 32 |
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| Secondary | Virologic Response at Week 40 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 40 |
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| Secondary | Virologic Response at Week 48 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 48 |
|
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| Secondary | Virologic Response at Week 56 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 56 |
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| Secondary | Virologic Response at Week 64 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 64 |
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| Secondary | Virologic Response at Week 72 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 72 |
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| Secondary | Virologic Response at Week 80 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 80 |
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| Secondary | Virologic Response at Week 88 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 88 |
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| Secondary | Virologic Response at Week 96 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1 | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 96 |
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| Secondary | Median Change From Baseline in Viral Load (Week 2) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 2 |
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| Secondary | Median Change From Baseline in Viral Load (Week 4) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 4 |
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| Secondary | Median Change From Baseline in Viral Load (Week 8) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 8 |
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| Secondary | Median Change From Baseline in Viral Load (Week 16) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 16 |
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| Secondary | Median Change From Baseline in Viral Load (Week 24) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 24 |
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| Secondary | Median Change From Baseline in Viral Load (Week 32) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 32 |
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| Secondary | Median Change From Baseline in Viral Load (Week 40) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 40 |
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| Secondary | Median Change From Baseline in Viral Load (Week 48) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 48 |
|
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| Secondary | Median Change From Baseline in Viral Load (Week 56) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Change From Baseline in Viral Load (Week 64) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 64 |
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| Secondary | Median Change From Baseline in Viral Load (Week 72) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 72 |
|
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| Secondary | Median Change From Baseline in Viral Load (Week 80) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 80 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Change From Baseline in Viral Load (Week 88) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 88 |
|
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| Secondary | Median Change From Baseline in Viral Load (Week 96) | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Log(Copies/mL) | Baseline to Week 96 |
|
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| Secondary | Virologic Response at Week 40 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 40 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 2 through Week 96 (at any point during trial) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 2 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 2 |
|
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| Secondary | Virologic Response at Week 4 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 4 |
|
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| Secondary | Virologic Response at Week 8 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 8 |
|
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| Secondary | Virologic Response at Week 16 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 16 |
|
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| Secondary | Virologic Response at Week 24 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 24 |
|
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| Secondary | Virologic Response at Week 32 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 32 |
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| Secondary | Virologic Response at Week 48 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 48 |
|
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| Secondary | Virologic Response at Week 56 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 64 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 64 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 72 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 72 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 80 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 80 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 88 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 88 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 96 | Virologic response defined as Viral Load<400 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 2 through Week 96 (at any point during trial) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 2 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 4 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 8 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 16 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 24 | Viral Load < 50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 32 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 32 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 40 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 40 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 48 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 56 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 64 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 64 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 72 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 72 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 80 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 80 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 88 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 88 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response at Week 96 | Virologic response defined as Viral Load<50 copies/mL | Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication | Posted | Number | Percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 2) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 4) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 8) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 16) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 24) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 32) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 32 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 40) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 40 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 48) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 56) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 64) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 64 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 72) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 72 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 80) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 80 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 88) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 88 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4+ Cell Count (Week 96) | Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline to Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. | Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition. The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time. | Safety Set (SAF), included all patients treated with at least one dose of study medication | Posted | Median | Inter-Quartile Range | Days | up to 75 weeks of treatment |
|
|
240 weeks
3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | 123 | 438 | 359 | 438 | |||
| EG001 | Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | 89 | 428 | 270 | 428 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Haematotoxicity | Blood and lymphatic system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Chorioretinitis | Eye disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Retinitis | Eye disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Oedema | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cholangitis chronic | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| AIDS encephalopathy | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Actinomycotic pulmonary infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Campylobacter intestinal infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Cryptosporidiosis infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Cyclosporidium infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Disseminated cryptococcosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Fungal oesophagitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis cryptosporidial | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Haemophilus sepsis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Helicobacter sepsis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Herpes oesophagitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Isosporiasis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Meningoencephalitis herpetic | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pneumocystis jiroveci infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Visceral leishmaniasis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Accident at home | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MEDDRA 11.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Electrocardiogram change | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Mitochondrial toxicity | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Anal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Hodgkin's disease mixed cellularity stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Recurrent cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Uterine carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cerebral ataxia | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cervical root pain | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Embolic cerebral infarction | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MEDDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Nephrogenic diabetes insipidus | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pulmonary cavitation | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Vocal cord thickening | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Eventration procedure | Surgical and medical procedures | MEDDRA 11.1 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MEDDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 11.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 11.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 11.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C107201 | tipranavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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