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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001784-21 | EudraCT Number |
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The study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-4250 monotherapy in anti-retroviral therapy (ART)-naïve, HIV-1 infected participants. The primary hypothesis of the study is that at a dose that is sufficiently safe and generally well tolerated, MK-4250 has superior antiretroviral activity compared to a historical placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) (log10 copies/mL) at 168 hours postdose.
The study consists of 5 panels; Panel C (MK-4250 ≤600 mg) was removed from the study with Protocol Amendment 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: MK-4250 150 mg | Experimental | Participants will receive MK-4250 150 mg tablet by mouth on Day 1 after an 8-hour fast. |
|
| Panel B: MK-4250 600 mg | Experimental | Participants will receive MK-4250 600 mg tablet by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) will be made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A. |
|
| Panel D: MK-4250 900 mg | Experimental | Participants will receive MK-4250 900 mg tablet by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D will be made upon completion of Panels A and B and evaluation of safety and viral load data from those panels. |
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| Panel E: MK-4250 ≤900 mg with a Low-fat Meal | Experimental | Participants will receive MK-4250 ≤900 mg tablet by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E will be made upon completion of Panel D and evaluation of safety and viral load data from that panel. |
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| Panel F: MK-4250 ≤900 mg with a Moderate-fat Meal | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4250 | Drug | MK-4250 tablets for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma HIV-1 RNA Copies Per mL at 168 Hours | Plasma HIV-1 RNA was measured at Baseline and 168 hours after dosing. The log10 plasma HIV-RNA copies/mL measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. The change from Baseline in plasma HIV-1 RNA in participants administered MK-4250 was compared with historical placebo data. | Baseline and Day 7 |
| Percentage of Participants Experiencing ≥1 Adverse Events (AE) | The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Up to Day 14 |
| Percentage of Participants Who Discontinued Study Due to an Adverse Event (AE) | The percentage of participants who discontinued from the study due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last) for MK-4250 | The area under the concentration-time curve up to the last measurable concentration (AUC0-last) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite Research Organisation GmbH ( Site 0001) | Berlin | 10117 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A: MK-4250 150 mg | Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast. |
| FG001 | Panel B: MK-4250 600 mg | Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A. |
| FG002 | Panel D: MK-4250 900 mg | Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels. |
| FG003 | Panel E: MK-4250 ≤900 mg With a Low-fat Meal | Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel. |
| FG004 | Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal | Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Panel F did not enroll because the scientific objectives were met following completion of Panel E.
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A: MK-4250 150 mg | Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast. |
| BG001 | Panel B: MK-4250 600 mg | Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Plasma HIV-1 RNA Copies Per mL at 168 Hours | Plasma HIV-1 RNA was measured at Baseline and 168 hours after dosing. The log10 plasma HIV-RNA copies/mL measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. The change from Baseline in plasma HIV-1 RNA in participants administered MK-4250 was compared with historical placebo data. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Least Squares Mean | 95% Confidence Interval | log10 copies per mL | Baseline and Day 7 |
|
Up to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening | This group represents all participants during their individual screening phase, approximately 4 weeks prior to first dose. No intervention was provided during this time. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2018 | Oct 7, 2019 | Prot_SAP_000.pdf |
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Participants will receive MK-4250 ≤900 mg tablet by mouth on Day 1 with a moderate-fat meal. The decision to enroll Panel F will be made upon completion of Panel D and evaluation of safety and viral load data from that panel. The decision to enroll Panel F will be made based on evaluation of PK and safety data from other studies with MK-4250.
|
| Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) for MK-4250 | The area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
| Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) for MK-4250 | The area under the concentration-time curve up to 168 hours (AUC0-168) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, and 168 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time. |
| Maximum Concentration (Cmax) of MK-4250 Reached in Plasma | The maximum concentration (Cmax) of MK-4250 in plasma was observed. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
| Concentration of MK-4250 at 168 Hours (C168hr) | The concentration of MK-4250 at 168 hours postdose (C168hr) was observed. | 168 hours after administration of MK-4250. |
| Apparent Terminal Half-life (t1/2) of MK-4250 | The apparent terminal half-life (t1/2) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
| Apparent Clearance (CL/F) of MK-4250 | The apparent clearance (CL/F) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
| Apparent Volume of Distribution (Vz/F) of MK-4250 | The apparent volume of distribution (Vz/F) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
| Time to Maximum Concentration (Tmax) of MK-4250 Reached in Plasma | The time to maximum concentration (Vz/F) of MK-4250 in plasma was calculated. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
| BG002 | Panel D: MK-4250 900 mg | Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels. |
| BG003 | Panel E: MK-4250 ≤900 mg With a Low-fat Meal | Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel. |
| BG004 | Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal | Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E. |
| BG005 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline Plasma HIV-1 Ribonucleic Acid (RNA) | log10 HIV-1 RNA copies per mL of blood at baseline are presented. | Mean | Standard Deviation | log10 copies/mL |
|
Participants received MK-4250 150 mg dose by mouth on Day 1 after an 8-hour fast.
| OG001 | Panel B: MK-4250 600 mg | Participants received MK-4250 600 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A. |
| OG002 | Panel D: MK-4250 900 mg | Participants received MK-4250 900 mg dose by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels. |
| OG003 | Panel E: MK-4250 ≤900 mg With a Low-fat Meal | Participants received MK-4250 900 mg dose by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel. |
| OG004 | Panel F: MK-4250 ≤900 mg With a Moderate-fat Meal | Participants were to receive MK-4250 900 mg dose by mouth on Day 1 with a moderate-fat meal. The decision was made not to enroll Panel F because the scientific objectives were met following completion of Panel E. |
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| Primary | Percentage of Participants Experiencing ≥1 Adverse Events (AE) | The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Included all participants who received ≥1 dose of treatment. Panel F did not enroll because the scientific objectives were met following completion of Panel E. | Posted | Number | Percentage of Participants | Up to Day 14 |
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|
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| Primary | Percentage of Participants Who Discontinued Study Due to an Adverse Event (AE) | The percentage of participants who discontinued from the study due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | Included all participants who received ≥1 dose of treatment. Panel F did not enroll because the scientific objectives were met following completion of Panel E. | Posted | Number | Percentage of Participants | Up to Day 14 |
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| Secondary | Area Under the Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last) for MK-4250 | The area under the concentration-time curve up to the last measurable concentration (AUC0-last) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM·hour | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
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| Secondary | Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) for MK-4250 | The area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM·hour | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
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| Secondary | Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) for MK-4250 | The area under the concentration-time curve up to 168 hours (AUC0-168) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM·Hour | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, and 168 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time. |
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| Secondary | Maximum Concentration (Cmax) of MK-4250 Reached in Plasma | The maximum concentration (Cmax) of MK-4250 in plasma was observed. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
|
|
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| Secondary | Concentration of MK-4250 at 168 Hours (C168hr) | The concentration of MK-4250 at 168 hours postdose (C168hr) was observed. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | 168 hours after administration of MK-4250. |
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|
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| Secondary | Apparent Terminal Half-life (t1/2) of MK-4250 | The apparent terminal half-life (t1/2) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
|
|
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| Secondary | Apparent Clearance (CL/F) of MK-4250 | The apparent clearance (CL/F) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/Hour | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
|
|
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| Secondary | Apparent Volume of Distribution (Vz/F) of MK-4250 | The apparent volume of distribution (Vz/F) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
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| Secondary | Time to Maximum Concentration (Tmax) of MK-4250 Reached in Plasma | The time to maximum concentration (Vz/F) of MK-4250 in plasma was calculated. | All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E. | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time. |
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|
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| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Panel A: 150 mg MK-4250 | Participants received MK-4250 150 mg tablet by mouth on Day 1 after an 8-hour fast. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | Panel B: 600 mg MK-4250 | Participants received MK-4250 600 mg tablet by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel B and the dose selected (i.e., ≤600 mg) was made based on evaluation of pharmacokinetics and 7-day safety and viral load data from Panel A. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Panel D: 900 mg MK-4250 | Participants received MK-4250 900 mg tablet by mouth on Day 1 after an 8-hour fast. The decision to enroll Panel D was made upon completion of Panels A and B and evaluation of safety and viral load data from those panels. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Panel E: 900 mg MK-4250, With a Low Fat Meal | Participants received MK-4250 ≤900 mg tablet by mouth on Day 1 with a low-fat meal. The decision to enroll Panel E was made upon completion of Panel D and evaluation of safety and viral load data from that panel. | 0 | 6 | 0 | 6 | 4 | 6 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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Subsequent to the multicenter publication (or after public disclosure of the results at www.clinicaltrials.gov if multicenter manuscript is not planned), an investigator and colleagues may publish their data independently. Sponsor must have opportunity to review proposed abstracts, manuscripts or presentations 45 days prior to submission for publication/presentation. Confidential information must be deleted prior to submission; this confidentiality does not include efficacy and safety results.