Trial Outcomes & Findings for Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI) (NCT NCT02066402)
NCT ID: NCT02066402
Last Updated: 2017-06-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
598 participants
Primary outcome timeframe
Baseline and 48-72 hours visit
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
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
|
Linezolid
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
298
|
|
Overall Study
Participants Received Treatment
|
292
|
297
|
|
Overall Study
Completed Study Treatment Period
|
261
|
256
|
|
Overall Study
COMPLETED
|
274
|
275
|
|
Overall Study
NOT COMPLETED
|
26
|
23
|
Reasons for withdrawal
| Measure |
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
|
Linezolid
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
14
|
11
|
|
Overall Study
Progressive disease-clinical progression
|
0
|
1
|
|
Overall Study
Protocol driven decision point
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Baseline characteristics by cohort
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
259 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
504 Participants
n=5 Participants
|
|
Age, Customized
65 - 75 years
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Customized
> 75 years
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Visual analog scale (VAS) pain scores
|
53.2 Units on a scale
STANDARD_DEVIATION 27.3 • n=5 Participants
|
53.9 Units on a scale
STANDARD_DEVIATION 28.7 • n=7 Participants
|
53.6 Units on a scale
STANDARD_DEVIATION 28.0 • n=5 Participants
|
|
Wong-Baker faces rating scale (FRS) pain scores
|
5.6 Units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
5.7 Units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
5.6 Units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Type of acute bacterial skin and skin structure infections (ABSSSI) infection
Cellulitis/erysipelas
|
192 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Type of acute bacterial skin and skin structure infections (ABSSSI) infection
Major cutaneous abscess
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Type of acute bacterial skin and skin structure infections (ABSSSI) infection
Wound infection
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 48-72 hours visitPopulation: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
|
75.3 Percentage of participants
|
79.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and EOT visit (Day 11)Population: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Clinical success
|
82.0 Percentage of participants
|
84.2 Percentage of participants
|
|
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Clinical failure or Indeterminate
|
18.0 Percentage of participants
|
15.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and EOT visit (Day 11)Population: CE-EOT
Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=242 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=243 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
Clinical success
|
89.7 Percentage of participants
|
91.8 Percentage of participants
|
|
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
Clinical failure or Indeterminate
|
10.3 Percentage of participants
|
8.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and post-therapy evaluation visit (7-14 days after Day 11)Population: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
Clinical success
|
79.7 Percentage of participants
|
81.9 Percentage of participants
|
|
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
Clinical failure or Indeterminate
|
20.3 Percentage of participants
|
18.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and post-therapy evaluation visit (7-14 days after Day 11)Population: CE-PTE
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=219 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=231 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
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
Clinical success
|
90.4 Percentage of participants
|
93.5 Percentage of participants
|
|
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
Clinical failure or Indeterminate
|
9.6 Percentage of participants
|
6.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and at 48-72 hoursPopulation: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Investigator's Assessment of Clinical Response at 48-72 Hours
Improving
|
86.7 Percentage of participants
|
90.3 Percentage of participants
|
|
Investigator's Assessment of Clinical Response at 48-72 Hours
Stable
|
4.7 Percentage of participants
|
3.0 Percentage of participants
|
|
Investigator's Assessment of Clinical Response at 48-72 Hours
Other
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Investigator's Assessment of Clinical Response at 48-72 Hours
Missing
|
8.0 Percentage of participants
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 7 visitPopulation: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Investigator's Assessment of Clinical Response at Day 7 Visit
Other
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
|
Investigator's Assessment of Clinical Response at Day 7 Visit
Missing
|
11.3 Percentage of participants
|
12.1 Percentage of participants
|
|
Investigator's Assessment of Clinical Response at Day 7 Visit
Improving
|
88.3 Percentage of participants
|
87.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to EOT visit (Day 11)Population: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
48-72 hours
|
30.2 Units on a scale
Standard Deviation 25.6
|
30.7 Units on a scale
Standard Deviation 25.7
|
|
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Day 2
|
40.9 Units on a scale
Standard Deviation 26.3
|
40.1 Units on a scale
Standard Deviation 26.5
|
|
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Day 7
|
18.8 Units on a scale
Standard Deviation 22.9
|
17.8 Units on a scale
Standard Deviation 21.2
|
|
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
EOT
|
11.6 Units on a scale
Standard Deviation 19.4
|
10.3 Units on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Up to EOT visit (Day 11)Population: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Day 2
|
-12.5 Units on a scale
Standard Deviation 21.7
|
-13.8 Units on a scale
Standard Deviation 20.1
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
48-72 hours
|
-23.2 Units on a scale
Standard Deviation 23.9
|
-23.2 Units on a scale
Standard Deviation 24.3
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Day 7
|
-34.7 Units on a scale
Standard Deviation 26.7
|
-36.1 Units on a scale
Standard Deviation 26.7
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
EOT
|
-41.6 Units on a scale
Standard Deviation 28.3
|
-43.6 Units on a scale
Standard Deviation 29.1
|
SECONDARY outcome
Timeframe: Up to EOT visit (Day 11)Population: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Day 2
|
4.1 Units on a scale
Standard Deviation 2.4
|
4.2 Units on a scale
Standard Deviation 2.5
|
|
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
48-72 hours
|
3.2 Units on a scale
Standard Deviation 2.4
|
3.2 Units on a scale
Standard Deviation 2.5
|
|
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Day 7
|
2.1 Units on a scale
Standard Deviation 2.3
|
2.0 Units on a scale
Standard Deviation 2.2
|
|
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
EOT
|
1.3 Units on a scale
Standard Deviation 2.0
|
1.3 Units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Up to EOT visit (Day 11)Population: ITT
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.
Outcome measures
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=300 Participants
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=298 Participants
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Day 2
|
-1.5 Units on a scale
Standard Deviation 2.0
|
-1.5 Units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
48-72 hours
|
-2.4 Units on a scale
Standard Deviation 2.2
|
-2.4 Units on a scale
Standard Deviation 2.3
|
|
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Day 7
|
-3.5 Units on a scale
Standard Deviation 2.6
|
-3.6 Units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
EOT
|
-4.2 Units on a scale
Standard Deviation 2.8
|
-4.4 Units on a scale
Standard Deviation 2.7
|
Adverse Events
Tedizolid Phosphate (Sivextro, BAY119-2631)
Serious events: 11 serious events
Other events: 60 other events
Deaths: 0 deaths
Linezolid
Serious events: 8 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=292 participants at risk
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=297 participants at risk
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
General disorders
Therapeutic product ineffective
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Abscess limb
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Anal abscess
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Cellulitis
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
1.3%
4/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Erysipelas
|
0.68%
2/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Haematoma infection
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Infected bite
|
0.00%
0/292 • From the start of study drug administration until last subject last visit.
|
0.34%
1/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Lung infection
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Skin bacterial infection
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Soft tissue infection
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Subcutaneous abscess
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/292 • From the start of study drug administration until last subject last visit.
|
0.34%
1/297 • From the start of study drug administration until last subject last visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/292 • From the start of study drug administration until last subject last visit.
|
0.34%
1/297 • From the start of study drug administration until last subject last visit.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.34%
1/292 • From the start of study drug administration until last subject last visit.
|
0.00%
0/297 • From the start of study drug administration until last subject last visit.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/292 • From the start of study drug administration until last subject last visit.
|
0.34%
1/297 • From the start of study drug administration until last subject last visit.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/292 • From the start of study drug administration until last subject last visit.
|
0.34%
1/297 • From the start of study drug administration until last subject last visit.
|
Other adverse events
| Measure |
Tedizolid Phosphate (Sivextro, BAY119-2631)
n=292 participants at risk
Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
|
Linezolid
n=297 participants at risk
Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
7/292 • From the start of study drug administration until last subject last visit.
|
2.7%
8/297 • From the start of study drug administration until last subject last visit.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
15/292 • From the start of study drug administration until last subject last visit.
|
4.7%
14/297 • From the start of study drug administration until last subject last visit.
|
|
General disorders
Fatigue
|
1.0%
3/292 • From the start of study drug administration until last subject last visit.
|
2.0%
6/297 • From the start of study drug administration until last subject last visit.
|
|
General disorders
Injection site extravasation
|
1.7%
5/292 • From the start of study drug administration until last subject last visit.
|
2.0%
6/297 • From the start of study drug administration until last subject last visit.
|
|
General disorders
Pyrexia
|
3.4%
10/292 • From the start of study drug administration until last subject last visit.
|
1.7%
5/297 • From the start of study drug administration until last subject last visit.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.68%
2/292 • From the start of study drug administration until last subject last visit.
|
2.4%
7/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Cellulitis
|
2.4%
7/292 • From the start of study drug administration until last subject last visit.
|
3.0%
9/297 • From the start of study drug administration until last subject last visit.
|
|
Infections and infestations
Skin bacterial infection
|
2.1%
6/292 • From the start of study drug administration until last subject last visit.
|
2.4%
7/297 • From the start of study drug administration until last subject last visit.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
7/292 • From the start of study drug administration until last subject last visit.
|
2.0%
6/297 • From the start of study drug administration until last subject last visit.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
7/292 • From the start of study drug administration until last subject last visit.
|
2.0%
6/297 • From the start of study drug administration until last subject last visit.
|
|
Nervous system disorders
Dizziness
|
1.0%
3/292 • From the start of study drug administration until last subject last visit.
|
2.4%
7/297 • From the start of study drug administration until last subject last visit.
|
|
Nervous system disorders
Headache
|
2.1%
6/292 • From the start of study drug administration until last subject last visit.
|
2.4%
7/297 • From the start of study drug administration until last subject last visit.
|
|
Vascular disorders
Phlebitis
|
3.1%
9/292 • From the start of study drug administration until last subject last visit.
|
0.67%
2/297 • From the start of study drug administration until last subject last visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60