Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.
Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.
ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Experimental | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo. |
|
| Linezolid | Active Comparator | Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tedizolid (BAY119-2631) | Drug | 50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit. | Baseline and 48-72 hours visit |
| Measure | Description | Time Frame |
|---|---|---|
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48-72 H Visit. |
Not provided
Inclusion Criteria:
Males or females >/=18 years old
Adequate venous access for a minimum of 2 I.V. doses of study drug
Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit
Suspected or documented gram-positive infection from baseline Gram stain or culture.
Exclusion Criteria:
Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
Infections associated with, or in close proximity to, a prosthetic device
Severe sepsis or septic shock
Known bacteremia at time of screening
ABSSSI due to or associated with any of the following:
Use of antibiotics as follows:
Administration of Linezolid within 30 days before the first infusion of the study drug
Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
Previous exposure to Tedizolid Phosphate treatment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chula Vista | California | 91911 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30988146 | Derived | Lv X, Alder J, Li L, O'Riordan W, Rybak MJ, Ye H, Zhang R, Zhang Z, Zhu X, Wilcox MH. Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection. Antimicrob Agents Chemother. 2019 Jun 24;63(7):e02252-18. doi: 10.1128/AAC.02252-18. Print 2019 Jul. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tedizolid Phosphate (Sivextro, BAY119-2631) | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo |
| FG001 | Linezolid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Tedizolid (BAY119-2631) | Drug | 50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days |
|
| Linezolid | Drug | 50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days |
|
| Placebo Linezolid | Drug | 50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days |
|
| Baseline and EOT visit (Day 11) |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate. | Baseline and EOT visit (Day 11) |
| Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. | Baseline and post-therapy evaluation visit (7-14 days after Day 11) |
| Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. | Baseline and post-therapy evaluation visit (7-14 days after Day 11) |
| Investigator's Assessment of Clinical Response at 48-72 Hours | The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other. | Baseline and at 48-72 hours |
| Investigator's Assessment of Clinical Response at Day 7 Visit | The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other. | Baseline and Day 7 visit |
| Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. | Up to EOT visit (Day 11) |
| Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. | Up to EOT visit (Day 11) |
| Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. | Up to EOT visit (Day 11) |
| Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. | Up to EOT visit (Day 11) |
| La Mesa |
| California |
| 91942 |
| United States |
| Oceanside | California | 92056 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Teaneck | New Jersey | 07666 | United States |
| Wuhu | Anhui | 241001 | China |
| Fuzhou | Fujian | 350025 | China |
| Guangzhou | Guangdong | 510120 | China |
| Guangzhou | Guangdong | 510180 | China |
| Wuhan | Hubei | 430030 | China |
| Changsha | Hunan | 410005 | China |
| Changsha | Hunan | 410013 | China |
| Changsha | Hunan | 410015 | China |
| Nanjing | Jiangsu | 210029 | China |
| Nanjing | Jiangsu | China |
| Suzhou | Jiangsu | 215006 | China |
| Wuxi | Jiangsu | China |
| Changchun | Jilin | 130021 | China |
| Dalian | Liaoning | 116027 | China |
| Shenyang | Liaoning | 110001 | China |
| Shenyang | Liaoning | 110016 | China |
| Xi'an | Shaanxi | 710038 | China |
| Xi'an | Shaanxi | 710061 | China |
| Jinan | Shandong | 250012 | China |
| Taiyuan | Shanxi | 030001 | China |
| Chengdu | Sichuan | 610041 | China |
| Ürümqi | Xinjiang | 830054 | China |
| Kunming | Yunnan | 650032 | China |
| Hangzhou | Zhejiang | 310003 | China |
| Hangzhou | Zhejiang | 310009 | China |
| Hangzhou | Zhejiang | 310014 | China |
| Hangzhou | Zhejiang | 310016 | China |
| Beijing | 100034 | China |
| Beijing | 100044 | China |
| Beijing | 100050 | China |
| Beijing | 100191 | China |
| Beijing | 100730 | China |
| Chongqing | 400042 | China |
| Shanghai | 200003 | China |
| Shanghai | 200025 | China |
| Shanghai | 200062 | China |
| Shanghai | 200092 | China |
| Shanghai | 201406 | China |
| Shanghai | 201700 | China |
| Tianjin | 300052 | China |
| Tianjin | 300121 | China |
| City of Taguig | Philippines |
| Quezon City | Philippines |
| Kaohsiung City | 807 | Taiwan |
| Kaohsiung City | 81362 | Taiwan |
| Taichung | 40447 | Taiwan |
| Tainan | 710 | Taiwan |
| Taipei | 10002 | Taiwan |
| Taipei | 116 | Taiwan |
| Taoyuan | 333 | Taiwan |
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
| Participants Received Treatment |
|
| Completed Study Treatment Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tedizolid Phosphate (Sivextro, BAY119-2631) | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo |
| BG001 | Linezolid | Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Visual analog scale (VAS) pain scores | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. | Mean | Standard Deviation | Units on a scale |
| |||||||||||||||||
| Wong-Baker faces rating scale (FRS) pain scores | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. | Mean | Standard Deviation | Units on a scale |
| |||||||||||||||||
| Type of acute bacterial skin and skin structure infections (ABSSSI) infection | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit. | ITT | Posted | Number | Percentage of participants | Baseline and 48-72 hours visit |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48-72 H Visit. | ITT | Posted | Number | Percentage of participants | Baseline and EOT visit (Day 11) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate. | CE-EOT | Posted | Number | Percentage of participants | Baseline and EOT visit (Day 11) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. | ITT | Posted | Number | Percentage of participants | Baseline and post-therapy evaluation visit (7-14 days after Day 11) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. | CE-PTE | Posted | Number | Percentage of participants | Baseline and post-therapy evaluation visit (7-14 days after Day 11) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator's Assessment of Clinical Response at 48-72 Hours | The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other. | ITT | Posted | Number | Percentage of participants | Baseline and at 48-72 hours |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator's Assessment of Clinical Response at Day 7 Visit | The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other. | ITT | Posted | Number | Percentage of participants | Baseline and Day 7 visit |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Up to EOT visit (Day 11) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Up to EOT visit (Day 11) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Up to EOT visit (Day 11) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Up to EOT visit (Day 11) |
|
|
From the start of study drug administration until last subject last visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tedizolid Phosphate (Sivextro, BAY119-2631) | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo | 11 | 292 | 60 | 292 | ||
| EG001 | Linezolid | Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days | 8 | 297 | 63 | 297 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Therapeutic product ineffective | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | +49 30 300139003 | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C546016 | tedizolid |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| > 75 years |
|
| Male |
|
| Major cutaneous abscess |
|
| Wound infection |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|