Acquired Immunodeficiency Syndrome, HIV Infections
Conditions
Brief summary
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
Interventions
DRUGComparator: MK0518
MK0518 oral tablets 200 mg b.i.d, for 24 weeks
DRUGMK0518
MK0518 oral tablets 400 mg b.i.d, for 24 weeks
DRUGPlacebo
Placebo to MK0518, oral tablet b.i.d, for 24 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study * Patient must be currently on antiretroviral therapy (ART)
Exclusion criteria
* Patient less than 18 years of age * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 | Baseline and Week 24 | Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CD4 Cell Count at Week 24 | Baseline and Week 24 | Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) |
| Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | 48 weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Serious CAEs at 48 Weeks | 48 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Number of Patients With Drug-related CAEs at 48 Weeks | 48 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs |
| Number of Patients With Serious Drug-related CAEs at 48 Weeks | 48 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. |
| Number of Patients That Died by 48 Weeks | 48 weeks | — |
| Number of Patients That Discontinued With CAEs at 48 Weeks | 48 weeks | — |
| Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | 48 weeks | — |
| Number of Patients That Discontinued With Serious CAEs at 48 Weeks | 48 weeks | — |
| Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | 48 weeks | — |
| Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | 48 weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Drug-related LAEs at 48 Weeks | 48 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs |
| Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | 48 weeks | — |
| Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | 48 weeks | — |
| Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | 96 weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Serious CAEs at 96 Weeks | 96 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Number of Patients With Drug-related CAEs at 96 Weeks | 96 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs |
| Number of Patients That Discontinued With Serious CAEs at 96 Weeks | 96 weeks | — |
| Number of Patients With Serious Drug-related CAEs at 96 Weeks | 96 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. |
| Number of Patients That Died by 96 Weeks | 96 weeks | — |
| Number of Patients That Discontinued With CAEs at 96 Weeks | 96 weeks | — |
| Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | 96 weeks | — |
| Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | 96 weeks | — |
| Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | 96 weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Drug-related LAEs at 96 Weeks | 96 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs |
| Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | 96 weeks | — |
| Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | 96 weeks | — |
| Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | 168 weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Serious CAEs at 168 Weeks | 168 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Number of Patients With Drug-related CAEs at 168 Weeks | 168 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs |
| Number of Patients With Serious Drug-related CAEs at 168 Weeks | 168 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. |
| Number of Patients That Died by 168 Weeks | 168 weeks | — |
| Number of Patients That Discontinued With CAEs at 168 Weeks | 168 weeks | — |
| Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | 168 weeks | — |
| Number of Patients That Discontinued With Serious CAEs at 168 Weeks | 168 weeks | — |
| Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | 168 weeks | — |
| Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | 168 weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Serious LAEs at 168 Weeks | 168 weeks | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | 168 weeks | — |
| Number of Patients With Virologic Responses at Week 24 | 24 weeks | Number of patients who achieve HIV RNA \<400 copies/mL; HIV RNA level \<50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24 |
| Number of Patients With Serious Drug-related LAEs at 168 Weeks | 168 weeks | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Number of Patients Discontinued With LAEs at 168 Weeks | 168 weeks | — |
| Number of Patients With Drug-related LAEs at 168 Weeks | 168 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | Baseline and Week 168 | Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases. |
| Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | Baseline and Week 168 | Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases. |
Participant flow
Recruitment details
Primary therapy period: 22-Apr-2005 to 09-Nov-2006 Multicenter (31) in the United States (15) and outside the United States (16)
Pre-assignment details
Patients failed prior antiretroviral therapy (HIV RNA \>5000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.
Participants by arm
| Arm | Count |
|---|---|
| MK0518 200 mg b.i.d. Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. | 43 |
| MK0518 400 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d. | 45 |
| MK0518 600 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. | 45 |
| Placebo OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. | 45 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind (DB) | Adverse Event | 2 | 0 | 1 | 1 |
| Double-Blind (DB) | Lack of Efficacy | 11 | 14 | 11 | 38 |
| Double-Blind (DB) | Never Treated | 1 | 0 | 0 | 0 |
| Open-Label Continuation of DB | Adverse Event | 3 | 1 | 0 | 0 |
| Open-Label Continuation of DB | Lack of Efficacy | 1 | 4 | 3 | 1 |
| Open-Label Continuation of DB | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Open-Label Continuation of DB | Patient did not continue in extension | 1 | 0 | 0 | 0 |
| Open-Label Continuation of DB | Patient moved/site stopped trial | 1 | 3 | 2 | 0 |
| Open-Label Continuation of DB | Withdrawal by Subject | 0 | 1 | 3 | 0 |
| Open-Label Post Virologic Failure(OLPVF) | Adverse Event | 0 | 0 | 0 | 1 |
| Open-Label Post Virologic Failure(OLPVF) | Lack of Efficacy | 7 | 6 | 5 | 10 |
| Open-Label Post Virologic Failure(OLPVF) | Lost to Follow-up | 1 | 0 | 0 | 1 |
| Open-Label Post Virologic Failure(OLPVF) | Patient moved/Site stopped trial | 1 | 0 | 1 | 1 |
| Open-Label Post Virologic Failure(OLPVF) | Withdrawal by Subject | 0 | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Total | Placebo | MK0518 600 mg b.i.d. | MK0518 200 mg b.i.d. | MK0518 400 mg b.i.d. |
|---|---|---|---|---|---|
| Age, Continuous | 44.1 years | 43.3 years | 43.8 years | 44.0 years | 45.1 years |
| Cluster of Differentiation 4 (CD4) Cell Count | 239.9 Cells/mm3 | 274.0 Cells/mm3 | 220.4 Cells/mm3 | 244.9 Cells/mm3 | 220.6 Cells/mm3 |
| Plasma HIV RNA | 4.7 log10 copies/mL | 4.7 log10 copies/mL | 4.7 log10 copies/mL | 4.6 log10 copies/mL | 4.8 log10 copies/mL |
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) | 49841.6 Copies/mL | 47432.6 Copies/mL | 49064.8 Copies/mL | 44642.6 Copies/mL | 59107.9 Copies/mL |
| Race/Ethnicity, Customized Asian | 3 participants | 1 participants | 2 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 20 participants | 5 participants | 7 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized Hispanic | 18 participants | 5 participants | 4 participants | 4 participants | 5 participants |
| Race/Ethnicity, Customized Others | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 136 participants | 33 participants | 32 participants | 36 participants | 35 participants |
| Sex: Female, Male Female | 21 Participants | 5 Participants | 4 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 157 Participants | 40 Participants | 41 Participants | 36 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 131 / 133 | 39 / 45 |
| serious Total, serious adverse events | 28 / 133 | 3 / 45 |
Outcome results
Primary
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
Time frame: Baseline and Week 24
Population: Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA \<400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 200 mg b.i.d. | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 | -1.80 HIV RNA (log10 copies/mL) |
| MK0518 400 mg b.i.d. | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 | -1.87 HIV RNA (log10 copies/mL) |
| MK0518 600 mg b.i.d. | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 | -1.84 HIV RNA (log10 copies/mL) |
| Placebo | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 | -0.35 HIV RNA (log10 copies/mL) |
Secondary
Change From Baseline in CD4 Cell Count at Week 24
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Time frame: Baseline and Week 24
Population: Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 200 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 24 | 62.9 CD4 Cell Count (cells/mm3) |
| MK0518 400 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 24 | 112.8 CD4 Cell Count (cells/mm3) |
| MK0518 600 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 24 | 94.1 CD4 Cell Count (cells/mm3) |
| Placebo | Change From Baseline in CD4 Cell Count at Week 24 | 5.4 CD4 Cell Count (cells/mm3) |
Secondary
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Discontinued With Drug-Related LAEs | 2 Participants |
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Did Not Discontinue With Drug-Related LAEs | 41 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Did Not Discontinue With Drug-Related LAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Discontinued With Drug-Related LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Discontinued With Drug-Related LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Did Not Discontinue With Drug-Related LAEs | 45 Participants |
| Placebo | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Discontinued With Drug-Related LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | Did Not Discontinue With Drug-Related LAEs | 45 Participants |
Secondary
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Discontinued With Drug-Related LAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Did Not Discontinue With Drug-Related LAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Did Not Discontinue With Drug-Related LAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Discontinued With Drug-Related LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Discontinued With Drug-Related LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Did Not Discontinue With Drug-Related LAEs | 45 Participants |
| Placebo | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Discontinued With Drug-Related LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | Did Not Discontinue With Drug-Related LAEs | 45 Participants |
Secondary
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication and had~any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Discontinued With Drug-related LAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Did Not Discontinue With Drug-related LAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Did Not Discontinue With Drug-related LAEs | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Discontinued With Drug-related LAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Discontinued With Drug-related LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Did Not Discontinue With Drug-related LAEs | 45 Participants |
| Placebo | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Discontinued With Drug-related LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | Did Not Discontinue With Drug-related LAEs | 45 Participants |
Secondary
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Discontinued With LAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Did Not Discontinue With LAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Discontinued With LAEs | 0 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Did Not Discontinue With LAEs | 45 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Did Not Discontinue With LAEs | 45 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Discontinued With LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Did Not Discontinue With LAEs | 45 Participants |
| Placebo | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Discontinued With LAEs | 0 Participants |
Secondary
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Discontinued With LAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Did Not Discontinue With LAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Did Not Discontinue With LAEs | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Discontinued With LAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Discontinued With LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Did Not Discontinue With LAEs | 45 Participants |
| Placebo | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Discontinued With LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Did Not Discontinue With LAEs | 45 Participants |
Secondary
Number of Patients Discontinued With LAEs at 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With LAEs at 168 Weeks | Discontinued With LAEs | 2 Participants |
| MK0518 200 mg b.i.d. | Number of Patients Discontinued With LAEs at 168 Weeks | Did Not Discontinue With LAEs | 41 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With LAEs at 168 Weeks | Did Not Discontinue With LAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients Discontinued With LAEs at 168 Weeks | Discontinued With LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With LAEs at 168 Weeks | Discontinued With LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients Discontinued With LAEs at 168 Weeks | Did Not Discontinue With LAEs | 45 Participants |
| Placebo | Number of Patients Discontinued With LAEs at 168 Weeks | Discontinued With LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued With LAEs at 168 Weeks | Did Not Discontinue With LAEs | 45 Participants |
Secondary
Number of Patients That Died by 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Died by 168 Weeks | Died | 3 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Died by 168 Weeks | Did not Die | 40 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 168 Weeks | Did not Die | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 168 Weeks | Died | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Died by 168 Weeks | Died | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Died by 168 Weeks | Did not Die | 44 Participants |
| Placebo | Number of Patients That Died by 168 Weeks | Died | 0 Participants |
| Placebo | Number of Patients That Died by 168 Weeks | Did not Die | 45 Participants |
Secondary
Number of Patients That Died by 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Died by 48 Weeks | Did not Die | 42 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Died by 48 Weeks | Died | 1 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 48 Weeks | Did not Die | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 48 Weeks | Died | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Died by 48 Weeks | Died | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Died by 48 Weeks | Did not Die | 44 Participants |
| Placebo | Number of Patients That Died by 48 Weeks | Died | 0 Participants |
| Placebo | Number of Patients That Died by 48 Weeks | Did not Die | 45 Participants |
Secondary
Number of Patients That Died by 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Died by 96 Weeks | Died | 2 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Died by 96 Weeks | Did Not Die | 41 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 96 Weeks | Did Not Die | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 96 Weeks | Died | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Died by 96 Weeks | Died | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Died by 96 Weeks | Did Not Die | 44 Participants |
| Placebo | Number of Patients That Died by 96 Weeks | Died | 0 Participants |
| Placebo | Number of Patients That Died by 96 Weeks | Did Not Die | 45 Participants |
Secondary
Number of Patients That Discontinued With CAEs at 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With CAEs at 168 Weeks | Discontinued With CAEs | 3 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With CAEs at 168 Weeks | Did Not Discontinue With CAEs | 40 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs at 168 Weeks | Did Not Discontinue With CAEs | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs at 168 Weeks | Discontinued With CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs at 168 Weeks | Discontinued With CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs at 168 Weeks | Did Not Discontinue With CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With CAEs at 168 Weeks | Discontinued With CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With CAEs at 168 Weeks | Did Not Discontinue With CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With CAEs at 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With CAEs at 48 Weeks | Discontinued With CAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With CAEs at 48 Weeks | Did Not Discontinue With CAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs at 48 Weeks | Did Not Discontinue With CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs at 48 Weeks | Discontinued With CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs at 48 Weeks | Discontinued With CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs at 48 Weeks | Did Not Discontinue With CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With CAEs at 48 Weeks | Discontinued With CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With CAEs at 48 Weeks | Did Not Discontinue With CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With CAEs at 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With CAEs at 96 Weeks | Discontinued With CAEs | 2 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With CAEs at 96 Weeks | Did Not Discontinue With CAEs | 41 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs at 96 Weeks | Did Not Discontinue With CAEs | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs at 96 Weeks | Discontinued With CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs at 96 Weeks | Discontinued With CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs at 96 Weeks | Did Not Discontinue With CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With CAEs at 96 Weeks | Discontinued With CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With CAEs at 96 Weeks | Did Not Discontinue With CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Discontinued With Drug-related CAEs | 0 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Did Not Discontinue With Drug-related CAEs | 43 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Did Not Discontinue With Drug-related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Discontinued With Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Discontinued With Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Did Not Discontinue With Drug-related CAEs | 45 Participants |
| Placebo | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Discontinued With Drug-related CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | Did Not Discontinue With Drug-related CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Discontinued With Drug-related CAEs | 0 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Did Not Discontinue With Drug-related CAEs | 43 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Did Not Discontinue With Drug-related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Discontinued With Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Discontinued With Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Did Not Discontinue With Drug-related CAEs | 45 Participants |
| Placebo | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Discontinued With Drug-related CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | Did Not Discontinue With Drug-related CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Discontinued With Drug-Related CAEs | 0 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Did Not Discontinue With Drug-Related CAEs | 43 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Did Not Discontinue With Drug-Related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Discontinued With Drug-Related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Discontinued With Drug-Related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Did Not Discontinue With Drug-Related CAEs | 45 Participants |
| Placebo | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Discontinued With Drug-Related CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | Did Not Discontinue With Drug-Related CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Serious CAEs at 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Did Not Discontinue With Serious CAEs | 40 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Discontinued With Serious CAEs | 3 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Discontinued With Serious CAEs | 1 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Discontinued With Serious CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | Discontinued With Serious CAEs | 1 Participants |
Secondary
Number of Patients That Discontinued With Serious CAEs at 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Discontinued With Serious CAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Did Not Discontinue With Serious CAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Did Not Discontinue With Serious CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Discontinued With Serious CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Discontinued With Serious CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Discontinued With Serious CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Serious CAEs at 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Discontinued With Serious CAEs | 2 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Did Not Discontinue With Serious CAEs | 41 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Discontinued With Serious CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Discontinued With Serious CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
| Placebo | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Discontinued With Serious CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | Did Not Discontinue With Serious CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 43 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 45 Participants |
| Placebo | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Discontinued With Serious Drug-related CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 43 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 45 Participants |
| Placebo | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Discontinued With Serious Drug-related CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 44 Participants |
Secondary
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 200 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 43 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Discontinued With Serious Drug-related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 45 Participants |
| Placebo | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Discontinued With Serious Drug-related CAEs | 1 Participants |
| Placebo | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | Did Not Discontinue With Serious Drug-related CAEs | 44 Participants |
Secondary
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | With CAEs | 43 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | Without CAEs | 0 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | Without CAEs | 2 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | With CAEs | 43 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | With CAEs | 45 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | Without CAEs | 0 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | With CAEs | 38 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks | Without CAEs | 7 Participants |
Secondary
Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | With CAEs | 37 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | Without CAEs | 6 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | Without CAEs | 8 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | With CAEs | 37 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | With CAEs | 41 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | Without CAEs | 4 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | With CAEs | 37 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks | Without CAEs | 8 Participants |
Secondary
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | With CAEs | 43 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | Without CAEs | 0 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | Without CAEs | 3 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | With CAEs | 42 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | With CAEs | 45 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | Without CAEs | 0 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | With CAEs | 38 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks | Without CAEs | 7 Participants |
Secondary
Number of Patients With Drug-related CAEs at 168 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related CAEs at 168 Weeks | With Drug-Related CAEs | 27 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related CAEs at 168 Weeks | Without Drug-Related CAEs | 16 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs at 168 Weeks | Without Drug-Related CAEs | 18 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs at 168 Weeks | With Drug-Related CAEs | 27 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs at 168 Weeks | With Drug-Related CAEs | 30 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs at 168 Weeks | Without Drug-Related CAEs | 15 Participants |
| Placebo | Number of Patients With Drug-related CAEs at 168 Weeks | With Drug-Related CAEs | 26 Participants |
| Placebo | Number of Patients With Drug-related CAEs at 168 Weeks | Without Drug-Related CAEs | 19 Participants |
Secondary
Number of Patients With Drug-related CAEs at 48 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related CAEs at 48 Weeks | With Drug-Related CAEs | 18 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related CAEs at 48 Weeks | Without Drug-Related CAEs | 25 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs at 48 Weeks | Without Drug-Related CAEs | 26 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs at 48 Weeks | With Drug-Related CAEs | 19 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs at 48 Weeks | With Drug-Related CAEs | 24 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs at 48 Weeks | Without Drug-Related CAEs | 21 Participants |
| Placebo | Number of Patients With Drug-related CAEs at 48 Weeks | With Drug-Related CAEs | 24 Participants |
| Placebo | Number of Patients With Drug-related CAEs at 48 Weeks | Without Drug-Related CAEs | 21 Participants |
Secondary
Number of Patients With Drug-related CAEs at 96 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related CAEs at 96 Weeks | With drug-related CAEs | 24 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related CAEs at 96 Weeks | Without drug-related CAEs | 19 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs at 96 Weeks | Without drug-related CAEs | 20 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs at 96 Weeks | With drug-related CAEs | 25 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs at 96 Weeks | With drug-related CAEs | 28 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs at 96 Weeks | Without drug-related CAEs | 17 Participants |
| Placebo | Number of Patients With Drug-related CAEs at 96 Weeks | With drug-related CAEs | 26 Participants |
| Placebo | Number of Patients With Drug-related CAEs at 96 Weeks | Without drug-related CAEs | 19 Participants |
Secondary
Number of Patients With Drug-related LAEs at 168 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 13 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 30 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 35 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 10 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 11 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 34 Participants |
| Placebo | Number of Patients With Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 9 Participants |
| Placebo | Number of Patients With Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 36 Participants |
Secondary
Number of Patients With Drug-related LAEs at 48 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 48 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related LAEs at 48 Weeks | With Drug-related LAEs | 7 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related LAEs at 48 Weeks | Without Drug-related LAEs | 36 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs at 48 Weeks | Without Drug-related LAEs | 37 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs at 48 Weeks | With Drug-related LAEs | 8 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs at 48 Weeks | With Drug-related LAEs | 7 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs at 48 Weeks | Without Drug-related LAEs | 38 Participants |
| Placebo | Number of Patients With Drug-related LAEs at 48 Weeks | With Drug-related LAEs | 8 Participants |
| Placebo | Number of Patients With Drug-related LAEs at 48 Weeks | Without Drug-related LAEs | 37 Participants |
Secondary
Number of Patients With Drug-related LAEs at 96 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related LAEs at 96 Weeks | With Drug-Related LAEs | 9 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Drug-related LAEs at 96 Weeks | Without Drug-Related LAEs | 34 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs at 96 Weeks | Without Drug-Related LAEs | 36 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs at 96 Weeks | With Drug-Related LAEs | 9 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs at 96 Weeks | With Drug-Related LAEs | 11 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs at 96 Weeks | Without Drug-Related LAEs | 34 Participants |
| Placebo | Number of Patients With Drug-related LAEs at 96 Weeks | With Drug-Related LAEs | 8 Participants |
| Placebo | Number of Patients With Drug-related LAEs at 96 Weeks | Without Drug-Related LAEs | 37 Participants |
Secondary
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | With LAEs | 17 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | Without LAEs | 26 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | Without LAEs | 29 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | With LAEs | 16 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | With LAEs | 18 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | Without LAEs | 27 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | With LAEs | 12 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks | Without LAEs | 33 Participants |
Secondary
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 48 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | With LAEs | 10 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Without LAEs | 33 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Without LAEs | 33 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | With LAEs | 12 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | With LAEs | 14 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Without LAEs | 31 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | With LAEs | 11 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks | Without LAEs | 34 Participants |
Secondary
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 96 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | With LAEs | 12 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Without LAEs | 31 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Without LAEs | 30 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | With LAEs | 15 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | With LAEs | 17 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Without LAEs | 28 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | With LAEs | 12 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks | Without LAEs | 33 Participants |
Secondary
Number of Patients With Serious CAEs at 168 Weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious CAEs at 168 Weeks | Without Serious CAEs | 37 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious CAEs at 168 Weeks | With Serious CAEs | 6 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs at 168 Weeks | With Serious CAEs | 13 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs at 168 Weeks | Without Serious CAEs | 32 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs at 168 Weeks | With Serious CAEs | 7 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs at 168 Weeks | Without Serious CAEs | 38 Participants |
| Placebo | Number of Patients With Serious CAEs at 168 Weeks | Without Serious CAEs | 42 Participants |
| Placebo | Number of Patients With Serious CAEs at 168 Weeks | With Serious CAEs | 3 Participants |
Secondary
Number of Patients With Serious CAEs at 48 Weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious CAEs at 48 Weeks | With Serious CAEs | 3 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious CAEs at 48 Weeks | Without Serious CAEs | 40 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs at 48 Weeks | Without Serious CAEs | 38 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs at 48 Weeks | With Serious CAEs | 7 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs at 48 Weeks | With Serious CAEs | 4 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs at 48 Weeks | Without Serious CAEs | 41 Participants |
| Placebo | Number of Patients With Serious CAEs at 48 Weeks | With Serious CAEs | 3 Participants |
| Placebo | Number of Patients With Serious CAEs at 48 Weeks | Without Serious CAEs | 42 Participants |
Secondary
Number of Patients With Serious CAEs at 96 Weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious CAEs at 96 Weeks | With Serious CAEs | 4 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious CAEs at 96 Weeks | Without Serious CAEs | 39 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs at 96 Weeks | Without Serious CAEs | 36 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs at 96 Weeks | With Serious CAEs | 9 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs at 96 Weeks | With Serious CAEs | 5 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs at 96 Weeks | Without Serious CAEs | 40 Participants |
| Placebo | Number of Patients With Serious CAEs at 96 Weeks | With Serious CAEs | 3 Participants |
| Placebo | Number of Patients With Serious CAEs at 96 Weeks | Without Serious CAEs | 42 Participants |
Secondary
Number of Patients With Serious Drug-related CAEs at 168 Weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 168 Weeks | With Serious Drug-Related CAEs | 2 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 168 Weeks | Without Serious Drug-Related CAEs | 41 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 168 Weeks | Without Serious Drug-Related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 168 Weeks | With Serious Drug-Related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 168 Weeks | With Serious Drug-Related CAEs | 2 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 168 Weeks | Without Serious Drug-Related CAEs | 43 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs at 168 Weeks | With Serious Drug-Related CAEs | 2 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs at 168 Weeks | Without Serious Drug-Related CAEs | 43 Participants |
Secondary
Number of Patients With Serious Drug-related CAEs at 48 Weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 48 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 48 Weeks | With Serious Drug-Related CAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 48 Weeks | Without Serious Drug-Related CAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 48 Weeks | Without Serious Drug-Related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 48 Weeks | With Serious Drug-Related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 48 Weeks | With Serious Drug-Related CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 48 Weeks | Without Serious Drug-Related CAEs | 44 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs at 48 Weeks | With Serious Drug-Related CAEs | 2 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs at 48 Weeks | Without Serious Drug-Related CAEs | 43 Participants |
Secondary
Number of Patients With Serious Drug-related CAEs at 96 Weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 96 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 96 Weeks | With Serious Drug-Related CAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 96 Weeks | Without Serious Drug-Related CAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 96 Weeks | Without Serious Drug-Related CAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 96 Weeks | With Serious Drug-Related CAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 96 Weeks | With Serious Drug-Related CAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs at 96 Weeks | Without Serious Drug-Related CAEs | 44 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs at 96 Weeks | With Serious Drug-Related CAEs | 2 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs at 96 Weeks | Without Serious Drug-Related CAEs | 43 Participants |
Secondary
Number of Patients With Serious Drug-related LAEs at 168 Weeks
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 44 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 1 Participants |
| Placebo | Number of Patients With Serious Drug-related LAEs at 168 Weeks | With Drug-related LAEs | 0 Participants |
| Placebo | Number of Patients With Serious Drug-related LAEs at 168 Weeks | Without Drug-related LAEs | 45 Participants |
Secondary
Number of Patients With Serious LAEs at 168 Weeks
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 168 weeks
Population: All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Serious LAEs at 168 Weeks | With Serious LAEs | 1 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Serious LAEs at 168 Weeks | Without Serious LAEs | 42 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious LAEs at 168 Weeks | Without Serious LAEs | 45 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious LAEs at 168 Weeks | With Serious LAEs | 0 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious LAEs at 168 Weeks | With Serious LAEs | 1 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious LAEs at 168 Weeks | Without Serious LAEs | 44 Participants |
| Placebo | Number of Patients With Serious LAEs at 168 Weeks | With Serious LAEs | 0 Participants |
| Placebo | Number of Patients With Serious LAEs at 168 Weeks | Without Serious LAEs | 45 Participants |
Secondary
Number of Patients With Virologic Responses at Week 24
Number of patients who achieve HIV RNA \<400 copies/mL; HIV RNA level \<50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24
Time frame: 24 weeks
Population: All patients who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | HIV RNA <400 copies/mL | 30 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | >1.0 log10 Drop in HIV RNA | 33 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | HIV RNA <50 copies/mL | 28 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | HIV RNA <400 copies/mL | 32 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | >1.0 log10 Drop in HIV RNA | 36 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | HIV RNA <50 copies/mL | 25 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | HIV RNA <50 copies/mL | 30 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | HIV RNA <400 copies/mL | 32 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Virologic Responses at Week 24 | >1.0 log10 Drop in HIV RNA | 36 Participants |
| Placebo | Number of Patients With Virologic Responses at Week 24 | HIV RNA <400 copies/mL | 7 Participants |
| Placebo | Number of Patients With Virologic Responses at Week 24 | >1.0 log10 Drop in HIV RNA | 8 Participants |
| Placebo | Number of Patients With Virologic Responses at Week 24 | HIV RNA <50 copies/mL | 6 Participants |
Other Pre-specified
Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies
Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.
Time frame: Baseline and Week 168
Population: Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 200 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | 96.9 CD4 Cell Count (cells/mm3) |
| MK0518 400 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | 107.7 CD4 Cell Count (cells/mm3) |
| MK0518 600 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | 147.4 CD4 Cell Count (cells/mm3) |
| Placebo | Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | 25.5 CD4 Cell Count (cells/mm3) |
Other Pre-specified
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies
Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.
Time frame: Baseline and Week 168
Population: Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 200 mg b.i.d. | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | -1.67 HIV RNA (log10 copies/mL) |
| MK0518 400 mg b.i.d. | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | -1.32 HIV RNA (log10 copies/mL) |
| MK0518 600 mg b.i.d. | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | -1.66 HIV RNA (log10 copies/mL) |
| Placebo | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | -0.33 HIV RNA (log10 copies/mL) |
Post Hoc
Number of Patients With Virologic Responses at Week 168 in Combined Substudies
Number of patients who achieve HIV RNA \<400 copies/mL; HIV RNA level \<50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168.
Time frame: 168 weeks
Population: Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 200 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <400 copies/mL | 21 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | >1.0 log10 Drop in HIV RNA | 22 Participants |
| MK0518 200 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <50 copies/mL | 20 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <400 copies/mL | 15 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | >1.0 log10 Drop in HIV RNA | 15 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <50 copies/mL | 13 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <50 copies/mL | 19 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <400 copies/mL | 22 Participants |
| MK0518 600 mg b.i.d. | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | >1.0 log10 Drop in HIV RNA | 23 Participants |
| Placebo | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <400 copies/mL | 5 Participants |
| Placebo | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | >1.0 log10 Drop in HIV RNA | 5 Participants |
| Placebo | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | HIV RNA <50 copies/mL | 5 Participants |