Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive cocci.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Daptomycin Participants aged 1 to 17 years old with cSSTI or bacteremia will receive daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia. |
Drug: Daptomycin for Injection
Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With an Adverse Event [Up to 56 days]
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
- Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE) [Up to 42 days]
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Secondary Outcome Measures
- Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success [Up to 7 days following end of treatment (up to 49 days)]
Clinical success in participants with MRSA infections was defined as either "Cure" - Resolution of clinically significant signs and symptoms associated with admission infection and no further antibiotic therapy required, OR "Improved"- partial resolution of clinical signs or symptoms of infection with no further antibiotic therapy required.
- Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response [Up to 7 days following end of treatment (up to 49 days)]
Participant-level microbiological response in participants with MRSA infections at baseline is defined as absence or presumed absence of all baseline infecting pathogens AND no gram-positive superinfection or gram-positive new infection, as assessed by infection site specimen culture or blood culture.
- Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin [Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment]
Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin.
- Maximum Plasma Concentration (Cmax) of Daptomycin [Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment]
Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin.
- Time to Maximum Plasma Concentration (Tmax) of Daptomycin [Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment]
Blood samples were collected at pre-specified time points to determine Tmax of daptomycin
- Body Weight Adjusted Clearance (CLss/wt) of Daptomycin [Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment]
Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state.
- Volume of Distribution at Steady State (Vss) of Daptomycin [Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment]
Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin.
- Apparent Terminal Half-Life (t½) of Daptomycin [Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment]
Blood samples were collected at pre-specified time points to determine the t½ of daptomycin.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Requires treatment for cSSTI or bacteremia.
-
Is male or female Japanese aged ≥ 1 to ≤ 17 years on the day of signing informed consent.
-
As a male participant, has agreed to use contraception during the treatment period and for at least 14 days after the last dose of study treatment and refrain from donating sperm during this period.
-
As a female participant, has agreed to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment.
-
Has agreed to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided the Central Microbiology Reference Laboratory for study-related microbiological testing, long-term storage, and other future testing.
cSSTI Participants
-
Has cSSTI known or suspected to be caused by gram-positive cocci that requires intravenous antibiotic treatment and diagnosed with either Gram stain or culture.
-
Has at least 3 of the following clinical signs and symptoms associated with the cSSTI: pain, tenderness to palpation, temperature >37.0°C axillary or >37.5°C oral or >38.0° C rectal, forehead, or aural, white blood count (WBC) >12,000/mm^3 or ≥10% bands, swelling and/or induration, erythema (>1 cm beyond edge of wound or abscess), pus formation, CRP > upper limited of normal.
Bacteremia Participants
-
Have proven bacteremia with pathogen identification of gram-positive cocci at least one blood culture bottle by conventional culture methods or by a rapid diagnostic test in screening period.
-
Have probable bacteremia with a blood culture result demonstrating gram-positive cocci by Gram stain in screening period.
Exclusion Criteria:
-
Has received previous systemic antimicrobial therapy that is effective against gram-positive cocci and exceeding 72 hours duration administered at any time during the 96 hours prior to the first dose of study drug.
-
Has a known infection caused solely by gram-negative pathogen(s), fungus(i) or virus(es).
-
Has pneumonia (septic emboli in the lung is not an exclusion if clear evidence of source of infection is other than lungs), empyema, meningitis, endocarditis, or osteoarticular infection.
-
Has a history of or current rhabdomyolysis.
-
Is anticipated to require non-study systemic antibiotics that may be potentially effective against gram-positive pathogen(s).
-
Has shock or hypotension unresponsive to fluids or vasopressors for ≥ 4 hours.
-
Has significant allergy/hypersensitivity or intolerance to daptomycin.
-
Has renal insufficiency.
-
Has a history of clinically significant (as assessed by the Investigator) muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre or spinal cord injury; previous uncomplicated febrile seizure allowed.
-
Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with the participant's participation for the full duration of the trial.
-
Is a female who is pregnant or is expecting to conceive (or is a male partner of a female who is expecting to conceive), is breastfeeding, or plans to breastfeed prior to completion of the study.
-
Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial.
-
Has previously participated in this study at any time.
-
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Japan Community Health Care Organization Chukyo Hospital ( Site 0030) | Nagoya | Aichi | Japan | 457-8510 |
| 2 | Japan Community Health care Organization Kyushu Hospital ( Site 0016) | Kitakyushu | Fukuoka | Japan | 806-8501 |
| 3 | Maebashi Red Cross Hospital ( Site 0012) | Maebashi | Gunma | Japan | 371-0811 |
| 4 | Kobe University Hospital ( Site 0015) | Kobe | Hyogo | Japan | 650-0017 |
| 5 | Shikoku Medical Center for Children and Adults ( Site 0027) | Zentsuji | Kagawa | Japan | 765-8507 |
| 6 | Showa University Fujigaoka Hospital ( Site 0023) | Yokohama | Kanagawa | Japan | 227-8501 |
| 7 | Kanagawa Children's Medical Center ( Site 0025) | Yokohama | Kanagawa | Japan | 232-8555 |
| 8 | National Hospital Organization National Mie Hospital ( Site 0002) | Tsu | Mie | Japan | 514-0125 |
| 9 | National Hospital Organization Beppu Medical Center ( Site 0003) | Beppu | Oita | Japan | 874-0011 |
| 10 | Tokyo Metropolitan Children's Medical Center ( Site 0004) | Fuchu | Tokyo | Japan | 183-8561 |
| 11 | Chiba University Hospital ( Site 0005) | Chiba | Japan | 260-8677 | |
| 12 | Chiba Children's Hospital ( Site 0024) | Chiba | Japan | 266-0007 | |
| 13 | National Hospital Organization Kumamoto Medical Center ( Site 0018) | Kumamoto | Japan | 860-0008 | |
| 14 | Osaka City General Hospital ( Site 0020) | Osaka | Japan | 534-0021 | |
| 15 | Saitama City Hospital ( Site 0008) | Saitama | Japan | 336-8522 | |
| 16 | Nihon University Itabashi Hospital ( Site 0029) | Tokyo | Japan | 173-8610 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- 3009-029
- MK-3009-029
- 184155
- 2020-001576-15
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Daptomycin |
|---|---|
| Arm/Group Description | Participants aged 1 to 17 years old with complicated skin and soft tissue infections (cSSTI) or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia. |
| Period Title: Overall Study | |
| STARTED | 18 |
| COMPLETED | 17 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Daptomycin |
|---|---|
| Arm/Group Description | Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia. |
| Overall Participants | 18 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
6.9
(5.1)
|
| Age, Customized (Number) [Number] | |
| Newborns (0-27 days) |
0
0%
|
| Infants and toddlers (28 days-23 months) |
5
27.8%
|
| Children (2-11 years) |
9
50%
|
| Adolescents (12-17 years) |
4
22.2%
|
| Adults (18-64 years) |
0
0%
|
| From 65-84 years |
0
0%
|
| 85 years and over |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
6
33.3%
|
| Male |
12
66.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
18
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
18
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Percentage of Participants With an Adverse Event |
|---|---|
| Description | An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. |
| Time Frame | Up to 56 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least one dose of daptomycin |
| Arm/Group Title | Daptomycin |
|---|---|
| Arm/Group Description | Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia. |
| Measure Participants | 18 |
| Number [Percentage of Participants] |
55.6
308.9%
|
| Title | Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE) |
|---|---|
| Description | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. |
| Time Frame | Up to 42 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least one dose of daptomycin |
| Arm/Group Title | Daptomycin |
|---|---|
| Arm/Group Description | Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia. |
| Measure Participants | 18 |
| Number [Percentage of Participants] |
0
0%
|
| Title | Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success |
|---|---|
| Description | Clinical success in participants with MRSA infections was defined as either "Cure" - Resolution of clinically significant signs and symptoms associated with admission infection and no further antibiotic therapy required, OR "Improved"- partial resolution of clinical signs or symptoms of infection with no further antibiotic therapy required. |
| Time Frame | Up to 7 days following end of treatment (up to 49 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants with cSSTI or bacteremia who had a positive culture of MRSA at baseline and received at least one dose of study treatment |
| Arm/Group Title | Daptomycin (MRSA With cSSTI) | Daptomycin (MRSA With Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants aged 1 to 17 years old with cSSTI and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-14 days. | Participants aged 1 to 17 years old with bacteremia and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 7 | 1 |
| Number (95% Confidence Interval) [Percentage of Participants] |
85.7
476.1%
|
100
NaN
|
| Title | Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response |
|---|---|
| Description | Participant-level microbiological response in participants with MRSA infections at baseline is defined as absence or presumed absence of all baseline infecting pathogens AND no gram-positive superinfection or gram-positive new infection, as assessed by infection site specimen culture or blood culture. |
| Time Frame | Up to 7 days following end of treatment (up to 49 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants with cSSTI or bacteremia who had a positive culture of MRSA at baseline and received at least one dose of study treatment |
| Arm/Group Title | Daptomycin (MRSA With cSSTI) | Daptomycin (MRSA With Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants aged 1 to 17 years old with cSSTI and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-14 days | Participants aged 1 to 17 years old with bacteremia and a positive culture of MRSA at baseline received daptomycin intravenously every 24 hours for 5-42 days |
| Measure Participants | 7 | 1 |
| Number (95% Confidence Interval) [Percentage of Participants] |
71.4
396.7%
|
100
NaN
|
| Title | Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin |
|---|---|
| Description | Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin. |
| Time Frame | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least 3 consecutive intravenous (IV) infusions of study treatment, had at least 1 pharmacokinetic (PK) sample following study drug administration, and did not have any protocol violations affecting the PK profile |
| Arm/Group Title | Daptomycin (cSSTI) | Daptomycin (Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants with cSSTI received daptomycin intravenously every 24 hours for 5-14 days. | Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 14 | 3 |
| Age Category 1-<2 years |
574
(99.1)
|
502
(0)
|
| Age Category 2-6 years |
431
(53.6)
|
|
| Age Category 7-11 years |
409
(143)
|
599
(0)
|
| Age Category 12-17 years |
316
(18.2)
|
422
(0)
|
| Title | Maximum Plasma Concentration (Cmax) of Daptomycin |
|---|---|
| Description | Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin. |
| Time Frame | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile |
| Arm/Group Title | Daptomycin (cSSTI) | Daptomycin (Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants diagnosed with cSSTI received daptomycin intravenously every 24 hours for 5-14 days. | Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 14 | 4 |
| Age Category 1-<2 years |
91.7
(6.66)
|
104
(8.70)
|
| Age Category 2-6 years |
80.3
(4.48)
|
|
| Age Category 7-11 years |
64.4
(15.1)
|
73.1
(0)
|
| Age Category 12-17 years |
49.3
(1.33)
|
94.0
(0)
|
| Title | Time to Maximum Plasma Concentration (Tmax) of Daptomycin |
|---|---|
| Description | Blood samples were collected at pre-specified time points to determine Tmax of daptomycin |
| Time Frame | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile |
| Arm/Group Title | Daptomycin (cSSTI) | Daptomycin (Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants with cSSTI received daptomycin intravenously every 24 hours for 5-14 days. | Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 14 | 4 |
| Age Category 1-<2 Years |
1.33
|
1.27
|
| Age Category 2-6 Years |
1.23
|
|
| Age Category 7-11 Years |
0.833
|
0.800
|
| Age Category 12-17 Years |
0.750
|
0.733
|
| Title | Body Weight Adjusted Clearance (CLss/wt) of Daptomycin |
|---|---|
| Description | Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state. |
| Time Frame | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile |
| Arm/Group Title | Daptomycin (cSSTI) | Daptomycin (Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants with cSSTI received daptomycin intravenously every 24 hours for 5-14 days. | Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 14 | 3 |
| Age Category 1-<2 Years |
17.8
(2.86)
|
23.9
(0)
|
| Age Category 2-6 Years |
21.1
(2.69)
|
|
| Age Category 7-11 Years |
19.4
(8.27)
|
15.0
(0)
|
| Age Category 12-17 Years |
15.8
(0.917)
|
16.6
(0)
|
| Title | Volume of Distribution at Steady State (Vss) of Daptomycin |
|---|---|
| Description | Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin. |
| Time Frame | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile |
| Arm/Group Title | Daptomycin (cSSTI) | Daptomycin (Bacteremia) |
|---|---|---|
| Arm/Group Description | Participants with cSSTI received daptomycin intravenously every 24 hours for 5-14 days. | Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 14 | 3 |
| Age Category 1-<2 Years |
1146
(299)
|
1918
(0)
|
| Age Category 2-6 Years |
1753
(486)
|
|
| Age Category 7-11 Years |
3929
(2032)
|
4013
(0)
|
| Age Category 12-17 Years |
6414
(1086)
|
5106
(0)
|
| Title | Apparent Terminal Half-Life (t½) of Daptomycin |
|---|---|
| Description | Blood samples were collected at pre-specified time points to determine the t½ of daptomycin. |
| Time Frame | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile |
| Arm/Group Title | Daptomycin (cSSTI) | Daptomycin (Bacterermia) |
|---|---|---|
| Arm/Group Description | Participants with cSSTI received daptomycin intravenously every 24 hours for 5-14 days. | Participants with bacteremia received daptomycin intravenously every 24 hours for 5-42 days. |
| Measure Participants | 14 | 3 |
| Age Category 1-<2 Years |
4.94
(0.460)
|
4.46
(0)
|
| Age Category 2-6 Years |
3.87
(0.514)
|
|
| Age Category 7-11 Years |
5.07
(1.09)
|
5.85
(0)
|
| Age Category 12-17 Years |
5.71
(0.942)
|
3.98
(0)
|
Adverse Events
| Time Frame | Up to 56 days | |
|---|---|---|
| Adverse Event Reporting Description | All enrolled participants who received at least one dose of daptomycin | |
| Arm/Group Title | Daptomycin | |
| Arm/Group Description | Participants aged 1 to 17 years old with cSSTI or bacteremia received daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia. | |
All Cause Mortality |
||
| Daptomycin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | |
Serious Adverse Events |
||
| Daptomycin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Daptomycin | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/18 (55.6%) | |
| Gastrointestinal disorders | ||
| Constipation | 1/18 (5.6%) | 1 |
| Enterocolitis | 1/18 (5.6%) | 1 |
| Gastrointestinal mucosal disorder | 1/18 (5.6%) | 1 |
| General disorders | ||
| Catheter site related reaction | 1/18 (5.6%) | 1 |
| Chills | 1/18 (5.6%) | 1 |
| Infusion site swelling | 1/18 (5.6%) | 1 |
| Injection site pain | 1/18 (5.6%) | 1 |
| Pyrexia | 2/18 (11.1%) | 2 |
| Infections and infestations | ||
| Gastroenteritis viral | 1/18 (5.6%) | 1 |
| Genital candidiasis | 1/18 (5.6%) | 1 |
| Nasopharyngitis | 1/18 (5.6%) | 1 |
| Investigations | ||
| Alanine aminotransferase increased | 1/18 (5.6%) | 1 |
| Platelet count increased | 1/18 (5.6%) | 1 |
| Weight decreased | 1/18 (5.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 1/18 (5.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Acne | 1/18 (5.6%) | 1 |
| Alopecia | 1/18 (5.6%) | 1 |
| Rash | 2/18 (11.1%) | 2 |
| Vascular disorders | ||
| Hypertension | 1/18 (5.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
- 3009-029
- MK-3009-029
- 184155
- 2020-001576-15