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The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNP-2092 | Experimental | TNP-2092 300 mg intravenous every 12 hours |
|
| Vancomycin | Active Comparator | vancomycin 1 g intravenous every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNP-2092 | Drug | TNP-2092 100mg/vial |
| |
| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. | 48 to 72 hours after the first dose of study treatment |
| Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. | 48 to 72 hours after the first dose of study treatment |
| Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). |
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Inclusion Criteria:
Subjects may be included in the study if they meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
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| Name | Affiliation | Role |
|---|---|---|
| TenNor Clinical Trials | TenNor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eStudy Site | San Diego | California | 92120 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TNP-2092 | TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial |
| FG001 | Vancomycin | vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TNP-2092 | TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial |
| BG001 | Vancomycin | vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. | Intent-to-Treat (mITT) Population: all randomized participants. | Posted | Count of Participants | Participants | 48 to 72 hours after the first dose of study treatment |
|
Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up.
Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
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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 | TNP-2092 | TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MRSA bacteremia and worsening cellulitis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment | Participant 002-0071 (TNP-2092 group) had a severe serious adverse event (SAE) of staphylococcal infection (MRSA bacteremia and worsening cellulitis) on Day 2, considered unrelated to study treatment and the SAE recovered on Day 8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhenkun Ma, PhD / CEO | TenNor Therapeutics Limited | +1(646) 775-1861 | zhenkun.ma@tennorx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2019 | Sep 13, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 19, 2019 | Sep 13, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000619733 | TNP-2092 |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
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| Drug |
Vancomycin 1g/vial |
|
| 48 to 72 hours after the first dose of study treatment |
| 7 to 14 days after the end of study treatment |
| Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | 7 to 14 days after the end of study treatment |
| Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | After a minimum of 7 days up to 14 days of study treatment |
| Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | After a minimum of 7 days up to 14 days of study treatment |
| AUC0-12h After First Infusion | Partial area under the concentration versus time curve from time zero to time 12 hours. | 0 to 12 hours post-dose |
| AUC0-12h After Last Infusion | Partial area under the concentration versus time curve from time zero to time 12 hours | 0 to 12 hours post-dose |
| Cmax After Last Infusion | Maximum observed concentration | 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion |
| Cmax After First Infusion | Maximum observed concentration | 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion |
| BG002 | 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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| Height | Mean | Standard Deviation | cm |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| Weight | Mean | Standard Deviation | kg |
|
TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial |
| OG001 | Vancomycin | vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial |
|
|
| Primary | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. | Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only | Posted | Count of Participants | Participants | 48 to 72 hours after the first dose of study treatment |
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|
|
| Primary | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. | Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants) | Posted | Count of Participants | Participants | 48 to 72 hours after the first dose of study treatment |
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|
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| Secondary | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only | Posted | Count of Participants | Participants | 7 to 14 days after the end of study treatment |
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|
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| Secondary | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants) | Posted | Count of Participants | Participants | 7 to 14 days after the end of study treatment |
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| Secondary | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only | Posted | Count of Participants | Participants | After a minimum of 7 days up to 14 days of study treatment |
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| Secondary | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). | Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants) | Posted | Count of Participants | Participants | After a minimum of 7 days up to 14 days of study treatment |
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| Secondary | AUC0-12h After First Infusion | Partial area under the concentration versus time curve from time zero to time 12 hours. | Participants that have sufficient plasma points for AUC 0-12h after first infusion analysis (26 Participants). | Posted | Mean | Standard Deviation | h*ng/mL | 0 to 12 hours post-dose |
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| Secondary | AUC0-12h After Last Infusion | Partial area under the concentration versus time curve from time zero to time 12 hours | Participants that have sufficient plasma points for AUC 0-12h after last infusion analysis (39 Participants) | Posted | Mean | Standard Deviation | h*ng/mL | 0 to 12 hours post-dose |
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| Secondary | Cmax After Last Infusion | Maximum observed concentration | Participants that have sufficient plasma points for Cmax after last infusion analysis (58 Participants) | Posted | Mean | Standard Deviation | ng/mL | 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion |
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| Secondary | Cmax After First Infusion | Maximum observed concentration | Participants that have sufficient plasma points for Cmax after first infusion analysis (68 Participants) | Posted | Mean | Standard Deviation | ng/mL | 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion |
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| 0 |
| 78 |
| 1 |
| 78 |
| 27 |
| 78 |
| EG001 | Vancomycin | vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial | 0 | 39 | 2 | 39 | 11 | 39 |
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| mental status changes | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment | Participant 002-0038 in the vancomycin group had a moderate SAE of mental status changes related to opioid overdose on Day 18. The SAE was considered unrelated to study treatment and the SAE recovered/resolved on Day 19. |
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| left upper extremity abscess,dehydration | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment | Participant 003-0031 in the vancomycin group had 2 SAEs: A severe SAE of left upper extremity abscess on Day 4. A severe SAE of dehydration on Day 47. The SAEs were considered unrelated to study drug. |
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| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| Indeterminate |
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| Indeterminate |
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| Indeterminate |
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| Indeterminate |
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| Indeterminate |
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| Indeterminate |
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