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Trial record 11 of 655 for:    Russian Federation | Chile

Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) (ZEPHYR)

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ClinicalTrials.gov Identifier: NCT00084266
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : May 9, 2011
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Methicillin Resistant Staphylococcus Aureus (MRSA)
Interventions Drug: linezolid (Zyvox)
Drug: vancomycin
Enrollment 1225
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Period Title: Overall Study
Started 618 607
Treated 597 587
Completed 177 184
Not Completed 441 423
Reason Not Completed
Death             42             39
Adverse Event             8             5
Lack of Efficacy             2             4
Lost to Follow-up             5             3
Participant not willing to participate             3             8
Other             360             344
Randomized not treated             21             20
Arm/Group Title Linezolid Vancomycin Total
Hide Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion. Total of all reporting groups
Overall Number of Baseline Participants 597 587 1184
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 597 participants 587 participants 1184 participants
60.5  (18.4) 60.5  (18.4) 60.5  (18.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 597 participants 587 participants 1184 participants
Female
202
  33.8%
207
  35.3%
409
  34.5%
Male
395
  66.2%
380
  64.7%
775
  65.5%
Clinical Signs and Symptoms for modified intent-to-treat (mITT) Population   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 597 participants 587 participants 1184 participants
Decreased Breath Sounds 169 182 351
Hypoxia 164 151 315
Pulmonary Consolidation 173 184 357
Rales 172 177 349
Tachypnea 152 143 295
Chills/Rigors 22 11 33
Cough 122 107 229
Dyspnea 99 95 194
Pleuritic Chest Pain 14 12 26
Purulent Sputum 167 209 376
[1]
Measure Description: Clinical signs and symptoms (mild to severe):cough;production of purulent sputum;auscultatory finding on pulmonary examination of rales,pulmonary consolidation(dullness on percussion, bronchial breath sounds,egophony);dyspnea, tachypnea,hypoxemia with partial pressure of oxygen(PaO2)<60 mmHg/worsening gas exchange/increased O2 requirement.
Clinical Signs and Symptoms for Per Protocol (PP) Population   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 597 participants 587 participants 1184 participants
Decreased Breath Sounds 138 155 293
Hypoxia 133 127 260
Pulmonary Consolidation 145 158 303
Rales 142 149 291
Tachypnea 124 123 247
Chills/Rigors 18 9 27
Cough 101 90 191
Dyspnea 80 80 160
Pleuritic Chest Pain 12 9 21
Purulent Sputum 171 174 345
[1]
Measure Description: Clinical signs and symptoms (mild to severe):cough;production of purulent sputum;auscultatory finding on pulmonary examination of rales,pulmonary consolidation(dullness on percussion, bronchial breath sounds,egophony);dyspnea, tachypnea,hypoxemia with PaO2<60 mmHg/worsening gas exchange/increased O2 requirement.
1.Primary Outcome
Title Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
Hide Description Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
Time Frame EOS (7-30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 165 174
Measure Type: Number
Unit of Measure: Participants
Cure 95 81
Failure 70 93
Unknown/Missing (excluded from analysis) 7 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as "cure".
Type of Statistical Test Non-Inferiority or Equivalence
Comments The final p-value was compared against an O'Brien-Fleming boundary of 0.048.
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population
Hide Description Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
Time Frame EOS (7-30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 186 205
Measure Type: Number
Unit of Measure: Participants
Cure 102 92
Failure 84 113
Unknown/Missing (excluded from analysis) 38 19
3.Secondary Outcome
Title Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Hide Description Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
Time Frame EOT (within 72 hours of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 180 186
Measure Type: Number
Unit of Measure: Participants
Cure 76 70
Improvement 74 60
Failure 30 56
Unknown/Missing (excluded from analysis) 3 2
4.Secondary Outcome
Title Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Hide Description Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
Time Frame EOT (within 72 hours of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 201 214
Measure Type: Number
Unit of Measure: Participants
Cure 81 77
Improvement 80 68
Failure 40 69
Unknown/Missing (excluded from analysis) 23 10
5.Secondary Outcome
Title Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Hide Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Time Frame EOS (7-30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 167 174
Measure Type: Number
Unit of Measure: Participants
MRSA Eradication 35 26
Presumed MRSA Eradication 62 56
MRSA Persistence 7 15
MRSA Recurrence 15 11
Presumed MRSA Persistence 48 66
Missing/Indeterminate (excluded from analysis) 5 2
6.Secondary Outcome
Title Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Hide Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Time Frame EOS (7-30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 195 209
Measure Type: Number
Unit of Measure: Participants
MRSA Eradication 46 35
Presumed MRSA Eradication 65 61
MRSA Persistence 9 22
MRSA Recurrence 16 12
Presumed MRSA Persistence 59 79
Missing/Indeterminate (excluded from analysis) 29 15
7.Secondary Outcome
Title Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Hide Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Time Frame EOT (within 72 hours of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 182 188
Measure Type: Number
Unit of Measure: Participants
MRSA Eradication 76 59
Presumed MRSA Eradication 73 55
MRSA Persistence 16 50
Presumed MRSA Persistence 17 24
Missing/Indeterminate (excluded from analysis) 1 0
8.Secondary Outcome
Title Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Hide Description Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Time Frame EOT (within 72 hours of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 203 218
Measure Type: Number
Unit of Measure: Participants
MRSA Eradication 84 65
Presumed MRSA Eradication 77 62
MRSA Persistence 19 60
Presumed MRSA Persistence 23 31
Missing/Indeterminate (excluded from analysis) 21 6
9.Secondary Outcome
Title Number of Participants With Clinical Signs and Symptoms at EOS for PP Population
Hide Description Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Time Frame EOS (7-30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 172 176
Measure Type: Number
Unit of Measure: Participants
Decreased Breath Sounds 42 46
Hypoxia 30 29
Pulmonary Consolidation 22 19
Rales 27 27
Tachypnea 39 36
Chills/Rigors 3 1
Cough 32 33
Dyspnea 15 19
Pleuritic Chest Pain 5 5
Purulent Sputum 36 26
10.Secondary Outcome
Title Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population
Hide Description Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Time Frame EOS (7-30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 224 224
Measure Type: Number
Unit of Measure: Participants
Decreased Breath Sounds 53 58
Hypoxia 38 38
Pulmonary Consolidation 32 27
Rales 36 34
Tachypnea 49 42
Chills/Rigors 4 2
Cough 37 40
Dyspnea 19 23
Pleuritic Chest Pain 7 6
Purulent Sputum 48 38
11.Secondary Outcome
Title Number of Participants With Clinical Signs and Symptoms at EOT for PP Population
Hide Description Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Time Frame EOT (within 72 hours of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 183 188
Measure Type: Number
Unit of Measure: Participants
Decreased Breath Sounds 63 99
Hypoxia 56 60
Pulmonary Consolidation 43 69
Rales 49 61
Tachypnea 67 58
Chills/Rigors 3 0
Cough 53 59
Dyspnea 24 27
Pleuritic Chest Pain 2 1
Purulent Sputum 55 74
12.Secondary Outcome
Title Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population
Hide Description Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Time Frame EOT (within 72 hours of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 224 224
Measure Type: Number
Unit of Measure: Participants
Decreased Breath Sounds 73 109
Hypoxia 67 73
Pulmonary Consolidation 53 77
Rales 57 73
Tachypnea 76 66
Chills/Rigors 5 2
Cough 64 64
Dyspnea 28 33
Pleuritic Chest Pain 4 2
Purulent Sputum 67 85
13.Secondary Outcome
Title Survival Status Estimated by Kaplan-Meier Analysis for PP Population
Hide Description For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
Time Frame From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 183 188
Mean (Standard Error)
Unit of Measure: Days
59.196  (1.684) 57.191  (1.686)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9344
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
14.Secondary Outcome
Title Survival Status Estimated by Kaplan-Meier Analysis for mITT Population
Hide Description For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
Time Frame From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 224 224
Median (Standard Error)
Unit of Measure: Days
58.185  (1.605) 57.072  (1.570)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5985
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
15.Secondary Outcome
Title Survival Status Estimated by Kaplan-Meier Analysis for ITT Population
Hide Description For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
Time Frame From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
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Hide Analysis Population Description
ITT population included all participants who received at least one dose of study medication.
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description:
Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Overall Number of Participants Analyzed 597 587
Mean (Standard Error)
Unit of Measure: Days
55.590  (1.511) 55.369  (1.484)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Vancomycin
Comments Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8590
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Linezolid Vancomycin
Hide Arm/Group Description Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion. Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
All-Cause Mortality
Linezolid Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Linezolid Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   145/597 (24.29%)   141/587 (24.02%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/597 (0.00%)  2/587 (0.34%) 
Disseminated intravascular coagulation * 1  1/597 (0.17%)  0/587 (0.00%) 
Haemorrhagic anaemia * 1  2/597 (0.34%)  0/587 (0.00%) 
Neutropenia * 1  0/597 (0.00%)  1/587 (0.17%) 
Thrombocytopenia * 1  1/597 (0.17%)  1/587 (0.17%) 
Thrombotic thrombocytopenic purpura * 1  0/597 (0.00%)  1/587 (0.17%) 
Cardiac disorders     
Acute myocardial infarction * 1  0/597 (0.00%)  2/587 (0.34%) 
Atrial fibrillation * 1  2/597 (0.34%)  3/587 (0.51%) 
Bradyarrhythmia * 1  0/597 (0.00%)  1/587 (0.17%) 
Bradycardia * 1  1/597 (0.17%)  2/587 (0.34%) 
Cardiac arrest * 1  11/597 (1.84%)  13/587 (2.21%) 
Cardiac failure congestive * 1  1/597 (0.17%)  5/587 (0.85%) 
Cardiac tamponade * 1  0/597 (0.00%)  1/587 (0.17%) 
Cardio-respiratory arrest * 1  9/597 (1.51%)  4/587 (0.68%) 
Cardiogenic shock * 1  2/597 (0.34%)  0/587 (0.00%) 
Cardiomyopathy * 1  1/597 (0.17%)  0/587 (0.00%) 
Cardiopulmonary failure * 1  1/597 (0.17%)  1/587 (0.17%) 
Coronary artery disease * 1  1/597 (0.17%)  1/587 (0.17%) 
Electromechanical dissociation * 1  2/597 (0.34%)  0/587 (0.00%) 
Myocardial infarction * 1  3/597 (0.50%)  0/587 (0.00%) 
Myocardial ischaemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Pericardial effusion * 1  1/597 (0.17%)  0/587 (0.00%) 
Pericarditis * 1  1/597 (0.17%)  0/587 (0.00%) 
Supraventricular tachycardia * 1  0/597 (0.00%)  1/587 (0.17%) 
Tachycardia * 1  1/597 (0.17%)  1/587 (0.17%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/597 (0.17%)  1/587 (0.17%) 
Ascites * 1  0/597 (0.00%)  2/587 (0.34%) 
Diarrhoea * 1  0/597 (0.00%)  1/587 (0.17%) 
Diverticular perforation * 1  1/597 (0.17%)  0/587 (0.00%) 
Diverticulum intestinal haemorrhagic * 1  1/597 (0.17%)  0/587 (0.00%) 
Enterocutaneous fistula * 1  0/597 (0.00%)  1/587 (0.17%) 
Gastric ulcer haemorrhage * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastrointestinal haemorrhage * 1  1/597 (0.17%)  1/587 (0.17%) 
Gastrointestinal necrosis * 1  0/597 (0.00%)  1/587 (0.17%) 
Ileus * 1  0/597 (0.00%)  1/587 (0.17%) 
Intestinal dilatation * 1  1/597 (0.17%)  0/587 (0.00%) 
Intestinal ischaemia * 1  2/597 (0.34%)  0/587 (0.00%) 
Intestinal perforation * 1  1/597 (0.17%)  0/587 (0.00%) 
Large intestine perforation * 1  1/597 (0.17%)  1/587 (0.17%) 
Lower gastrointestinal haemorrhage * 1  1/597 (0.17%)  0/587 (0.00%) 
Mesenteric vein thrombosis * 1  1/597 (0.17%)  0/587 (0.00%) 
Nausea * 1  0/597 (0.00%)  1/587 (0.17%) 
Oesophageal achalasia * 1  1/597 (0.17%)  0/587 (0.00%) 
Oesophageal varices haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Pancreatitis * 1  2/597 (0.34%)  0/587 (0.00%) 
Peritonitis * 1  1/597 (0.17%)  2/587 (0.34%) 
Small intestinal perforation * 1  1/597 (0.17%)  0/587 (0.00%) 
Upper gastrointestinal haemorrhage * 1  1/597 (0.17%)  2/587 (0.34%) 
Vomiting * 1  0/597 (0.00%)  1/587 (0.17%) 
General disorders     
Drug ineffective * 1  1/597 (0.17%)  0/587 (0.00%) 
Multi-organ disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Multi-organ failure * 1  7/597 (1.17%)  3/587 (0.51%) 
Pyrexia * 1  2/597 (0.34%)  0/587 (0.00%) 
Secretion discharge * 1  1/597 (0.17%)  0/587 (0.00%) 
Hepatobiliary disorders     
Cholecystitis * 1  2/597 (0.34%)  0/587 (0.00%) 
Cholecystitis acute * 1  1/597 (0.17%)  0/587 (0.00%) 
Hepatic cirrhosis * 1  0/597 (0.00%)  1/587 (0.17%) 
Ischaemic hepatitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Liver disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  0/597 (0.00%)  1/587 (0.17%) 
Infections and infestations     
Abdominal abscess * 1  1/597 (0.17%)  0/587 (0.00%) 
Abdominal infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Abdominal sepsis * 1  0/597 (0.00%)  1/587 (0.17%) 
Abscess intestinal * 1  0/597 (0.00%)  1/587 (0.17%) 
Acinetobacter bacteraemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Acinetobacter infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Bacterial sepsis * 1  1/597 (0.17%)  1/587 (0.17%) 
Candidiasis * 1  0/597 (0.00%)  1/587 (0.17%) 
Cellulitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Clostridial infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Clostridium colitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Clostridium difficile colitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Device related infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Diverticulitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Endocarditis * 1  1/597 (0.17%)  0/587 (0.00%) 
Fungal sepsis * 1  0/597 (0.00%)  1/587 (0.17%) 
Gangrene * 1  1/597 (0.17%)  0/587 (0.00%) 
Kidney infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Lung infection pseudomonal * 1  1/597 (0.17%)  2/587 (0.34%) 
Meningitis bacterial * 1  1/597 (0.17%)  0/587 (0.00%) 
Muscle abscess * 1  1/597 (0.17%)  0/587 (0.00%) 
Parotitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Pneumonia * 1  14/597 (2.35%)  9/587 (1.53%) 
Pneumonia bacterial * 1  1/597 (0.17%)  3/587 (0.51%) 
Pneumonia klebsiella * 1  2/597 (0.34%)  0/587 (0.00%) 
Pneumonia staphylococcal * 1  1/597 (0.17%)  3/587 (0.51%) 
Post procedural sepsis * 1  1/597 (0.17%)  0/587 (0.00%) 
Postoperative abscess * 1  1/597 (0.17%)  0/587 (0.00%) 
Postoperative wound infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Pseudomonal bacteraemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Pseudomonas infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Pyothorax * 1  0/597 (0.00%)  1/587 (0.17%) 
Sepsis * 1  9/597 (1.51%)  19/587 (3.24%) 
Septic shock * 1  9/597 (1.51%)  16/587 (2.73%) 
Staphylococcal infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Staphylococcal sepsis * 1  2/597 (0.34%)  0/587 (0.00%) 
Systemic candida * 1  1/597 (0.17%)  2/587 (0.34%) 
Toxic shock syndrome streptococcal * 1  0/597 (0.00%)  1/587 (0.17%) 
Tracheobronchitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Urinary tract infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Wound infection staphylococcal * 1  1/597 (0.17%)  0/587 (0.00%) 
Injury, poisoning and procedural complications     
Anastomotic complication * 1  0/597 (0.00%)  1/587 (0.17%) 
Brain herniation * 1  1/597 (0.17%)  0/587 (0.00%) 
Failure to anastomose * 1  1/597 (0.17%)  0/587 (0.00%) 
Fall * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastrointestinal stoma complication * 1  0/597 (0.00%)  1/587 (0.17%) 
Pneumothorax traumatic * 1  0/597 (0.00%)  1/587 (0.17%) 
Post procedural fistula * 1  1/597 (0.17%)  1/587 (0.17%) 
Postoperative ileus * 1  1/597 (0.17%)  0/587 (0.00%) 
Seroma * 1  1/597 (0.17%)  1/587 (0.17%) 
Tracheal obstruction * 1  0/597 (0.00%)  1/587 (0.17%) 
Tracheostomy malfunction * 1  0/597 (0.00%)  1/587 (0.17%) 
Wound dehiscence * 1  1/597 (0.17%)  1/587 (0.17%) 
Wound evisceration * 1  0/597 (0.00%)  1/587 (0.17%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/597 (0.00%)  1/587 (0.17%) 
Hyperkalaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Hypoglycaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Musculoskeletal and connective tissue disorders     
Bursitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Fistula * 1  0/597 (0.00%)  1/587 (0.17%) 
Osteonecrosis * 1  1/597 (0.17%)  0/587 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Central nervous system lymphoma * 1  1/597 (0.17%)  0/587 (0.00%) 
Neuroendocrine carcinoma * 1  1/597 (0.17%)  0/587 (0.00%) 
Squamous cell carcinoma * 1  0/597 (0.00%)  1/587 (0.17%) 
Ureteric cancer metastatic * 1  1/597 (0.17%)  0/587 (0.00%) 
Nervous system disorders     
Brain compression * 1  1/597 (0.17%)  0/587 (0.00%) 
Brain oedema * 1  3/597 (0.50%)  0/587 (0.00%) 
Cerebral ischaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Cerebrovascular accident * 1  2/597 (0.34%)  3/587 (0.51%) 
Coma * 1  0/597 (0.00%)  1/587 (0.17%) 
Convulsion * 1  1/597 (0.17%)  1/587 (0.17%) 
Depressed level of consciousness * 1  1/597 (0.17%)  0/587 (0.00%) 
Haemorrhage intracranial * 1  1/597 (0.17%)  2/587 (0.34%) 
Haemorrhagic stroke * 1  0/597 (0.00%)  1/587 (0.17%) 
Headache * 1  0/597 (0.00%)  1/587 (0.17%) 
Hydrocephalus * 1  1/597 (0.17%)  0/587 (0.00%) 
Hypoxic-ischaemic encephalopathy * 1  0/597 (0.00%)  2/587 (0.34%) 
Ischaemic stroke * 1  1/597 (0.17%)  2/587 (0.34%) 
Mental impairment * 1  1/597 (0.17%)  0/587 (0.00%) 
Nervous system disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Neurological decompensation * 1  0/597 (0.00%)  1/587 (0.17%) 
Pneumocephalus * 1  1/597 (0.17%)  0/587 (0.00%) 
Polyneuropathy * 1  0/597 (0.00%)  1/587 (0.17%) 
Subarachnoid haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Subdural hygroma * 1  0/597 (0.00%)  1/587 (0.17%) 
Unresponsive to stimuli * 1  1/597 (0.17%)  0/587 (0.00%) 
Psychiatric disorders     
Mental status changes * 1  0/597 (0.00%)  3/587 (0.51%) 
Renal and urinary disorders     
Azotaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Renal failure * 1  2/597 (0.34%)  6/587 (1.02%) 
Renal failure acute * 1  5/597 (0.84%)  11/587 (1.87%) 
Renal failure chronic * 1  1/597 (0.17%)  0/587 (0.00%) 
Renal impairment * 1  3/597 (0.50%)  1/587 (0.17%) 
Urinary retention * 1  1/597 (0.17%)  0/587 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acquired tracheo-oesophageal fistula * 1  1/597 (0.17%)  0/587 (0.00%) 
Acute respiratory distress syndrome * 1  3/597 (0.50%)  1/587 (0.17%) 
Acute respiratory failure * 1  1/597 (0.17%)  1/587 (0.17%) 
Apnoea * 1  0/597 (0.00%)  1/587 (0.17%) 
Asphyxia * 1  1/597 (0.17%)  0/587 (0.00%) 
Aspiration * 1  0/597 (0.00%)  1/587 (0.17%) 
Atelectasis * 1  1/597 (0.17%)  0/587 (0.00%) 
Brain hypoxia * 1  1/597 (0.17%)  0/587 (0.00%) 
Bronchial secretion retention * 1  1/597 (0.17%)  1/587 (0.17%) 
Bronchospasm * 1  1/597 (0.17%)  0/587 (0.00%) 
Chronic obstructive pulmonary disease * 1  2/597 (0.34%)  0/587 (0.00%) 
Dependence on respirator * 1  0/597 (0.00%)  1/587 (0.17%) 
Epistaxis * 1  2/597 (0.34%)  0/587 (0.00%) 
Haemoptysis * 1  0/597 (0.00%)  2/587 (0.34%) 
Hypoventilation * 1  1/597 (0.17%)  0/587 (0.00%) 
Hypoxia * 1  3/597 (0.50%)  1/587 (0.17%) 
Lung disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Lung infiltration * 1  0/597 (0.00%)  1/587 (0.17%) 
Organising pneumon * 1  1/597 (0.17%)  0/587 (0.00%) 
Pleural effusion * 1  5/597 (0.84%)  0/587 (0.00%) 
Pneumonia aspiration * 1  2/597 (0.34%)  1/587 (0.17%) 
Pneumothorax * 1  2/597 (0.34%)  0/587 (0.00%) 
Pulmonary embolism * 1  3/597 (0.50%)  1/587 (0.17%) 
Pulmonary oedema * 1  1/597 (0.17%)  1/587 (0.17%) 
Respiratory acidosis * 1  1/597 (0.17%)  0/587 (0.00%) 
Respiratory arrest * 1  1/597 (0.17%)  5/587 (0.85%) 
Respiratory disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Respiratory distress * 1  3/597 (0.50%)  2/587 (0.34%) 
Respiratory failure * 1  17/597 (2.85%)  18/587 (3.07%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/597 (0.17%)  0/587 (0.00%) 
Surgical and medical procedures     
Tracheal operation * 1  0/597 (0.00%)  1/587 (0.17%) 
Vascular disorders     
Aortic dissection * 1  1/597 (0.17%)  0/587 (0.00%) 
Circulatory collapse * 1  1/597 (0.17%)  0/587 (0.00%) 
Deep vein thrombosis * 1  0/597 (0.00%)  2/587 (0.34%) 
Haemorrhage * 1  0/597 (0.00%)  2/587 (0.34%) 
Hypotension * 1  5/597 (0.84%)  6/587 (1.02%) 
Peripheral arterial occlusive disease * 1  1/597 (0.17%)  0/587 (0.00%) 
Shock * 1  1/597 (0.17%)  1/587 (0.17%) 
Shock haemorrhagic * 1  0/597 (0.00%)  1/587 (0.17%) 
Venous thrombosis * 1  1/597 (0.17%)  0/587 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Linezolid Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   348/597 (58.29%)   381/587 (64.91%) 
Blood and lymphatic system disorders     
Anaemia * 1  30/597 (5.03%)  40/587 (6.81%) 
Coagulopathy * 1  1/597 (0.17%)  3/587 (0.51%) 
Eosinophilia * 1  2/597 (0.34%)  2/587 (0.34%) 
Haemorrhagic anaemia * 1  4/597 (0.67%)  2/587 (0.34%) 
Heparin-induced thrombocytopenia * 1  0/597 (0.00%)  2/587 (0.34%) 
Hypoprothrombinaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Leukocytosis * 1  2/597 (0.34%)  5/587 (0.85%) 
Lymphopenia * 1  0/597 (0.00%)  1/587 (0.17%) 
Neutropenia * 1  2/597 (0.34%)  0/587 (0.00%) 
Pancytopenia * 1  2/597 (0.34%)  1/587 (0.17%) 
Thrombocytopenia * 1  7/597 (1.17%)  12/587 (2.04%) 
Thrombocytosis * 1  2/597 (0.34%)  6/587 (1.02%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/597 (0.00%)  1/587 (0.17%) 
Angina pectoris * 1  5/597 (0.84%)  1/587 (0.17%) 
Arrhythmia * 1  4/597 (0.67%)  2/587 (0.34%) 
Arrhythmia supraventricular * 1  1/597 (0.17%)  0/587 (0.00%) 
Atrial fibrillation * 1  10/597 (1.68%)  13/587 (2.21%) 
Atrial flutter * 1  1/597 (0.17%)  0/587 (0.00%) 
Atrial tachycardia * 1  1/597 (0.17%)  0/587 (0.00%) 
Bradyarrhythmia * 1  0/597 (0.00%)  1/587 (0.17%) 
Bradycardia * 1  9/597 (1.51%)  7/587 (1.19%) 
Cardiac failure * 1  0/597 (0.00%)  1/587 (0.17%) 
Cardiac failure congestive * 1  3/597 (0.50%)  3/587 (0.51%) 
Cardio-respiratory arrest * 1  0/597 (0.00%)  1/587 (0.17%) 
Coronary artery disease * 1  0/597 (0.00%)  1/587 (0.17%) 
Cyanosis * 1  1/597 (0.17%)  0/587 (0.00%) 
Extrasystoles * 1  0/597 (0.00%)  1/587 (0.17%) 
Left ventricular failure * 1  0/597 (0.00%)  1/587 (0.17%) 
Myocardial infarction * 1  2/597 (0.34%)  1/587 (0.17%) 
Pericardial effusion * 1  1/597 (0.17%)  0/587 (0.00%) 
Postural orthostatic tachycardia syndrome * 1  1/597 (0.17%)  0/587 (0.00%) 
Sinus bradycardia * 1  0/597 (0.00%)  2/587 (0.34%) 
Sinus tachycardia * 1  0/597 (0.00%)  1/587 (0.17%) 
Supraventricular extrasystoles * 1  0/597 (0.00%)  1/587 (0.17%) 
Supraventricular tachycardia * 1  7/597 (1.17%)  5/587 (0.85%) 
Tachycardia * 1  11/597 (1.84%)  11/587 (1.87%) 
Torsade de pointes * 1  1/597 (0.17%)  0/587 (0.00%) 
Ventricular dysfunction * 1  1/597 (0.17%)  0/587 (0.00%) 
Ventricular extrasystoles * 1  2/597 (0.34%)  1/587 (0.17%) 
Ventricular tachycardia * 1  6/597 (1.01%)  5/587 (0.85%) 
Ear and labyrinth disorders     
Ear pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Hypoacusis * 1  1/597 (0.17%)  0/587 (0.00%) 
Otorrhoea * 1  0/597 (0.00%)  1/587 (0.17%) 
Endocrine disorders     
Adrenal insufficiency * 1  3/597 (0.50%)  0/587 (0.00%) 
Diabetes insipidus * 1  1/597 (0.17%)  1/587 (0.17%) 
Hyperparathyroidism * 1  1/597 (0.17%)  0/587 (0.00%) 
Hyperthyroidism * 1  0/597 (0.00%)  1/587 (0.17%) 
Hypothyroidism * 1  0/597 (0.00%)  1/587 (0.17%) 
Eye disorders     
Conjunctivitis * 1  2/597 (0.34%)  6/587 (1.02%) 
Corneal disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Dry eye * 1  0/597 (0.00%)  2/587 (0.34%) 
Ocular discomfort * 1  0/597 (0.00%)  1/587 (0.17%) 
Pupillary reflex impaired * 1  0/597 (0.00%)  1/587 (0.17%) 
Pupils unequal * 1  0/597 (0.00%)  1/587 (0.17%) 
Uveitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Periorbital oedema * 1  0/597 (0.00%)  1/587 (0.17%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  6/597 (1.01%)  0/587 (0.00%) 
Abdominal distension * 1  3/597 (0.50%)  4/587 (0.68%) 
Abdominal pain * 1  4/597 (0.67%)  4/587 (0.68%) 
Abdominal pain upper * 1  2/597 (0.34%)  3/587 (0.51%) 
Anal ulcer * 1  1/597 (0.17%)  0/587 (0.00%) 
Anorectal discomfort * 1  1/597 (0.17%)  0/587 (0.00%) 
Ascites * 1  2/597 (0.34%)  1/587 (0.17%) 
Colonic polyp * 1  1/597 (0.17%)  0/587 (0.00%) 
Constipation * 1  33/597 (5.53%)  37/587 (6.30%) 
Diarrhoea * 1  59/597 (9.88%)  56/587 (9.54%) 
Dry mouth * 1  0/597 (0.00%)  1/587 (0.17%) 
Duodenal ulcer haemorrhage * 1  2/597 (0.34%)  1/587 (0.17%) 
Dyspepsia * 1  3/597 (0.50%)  3/587 (0.51%) 
Dysphagia * 1  7/597 (1.17%)  8/587 (1.36%) 
Enterocutaneous fistula * 1  0/597 (0.00%)  1/587 (0.17%) 
Enterovesical fistula * 1  1/597 (0.17%)  0/587 (0.00%) 
Flatulence * 1  1/597 (0.17%)  1/587 (0.17%) 
Gastric disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastric hypomotility * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastric ulcer * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastric ulcer haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Gastritis erosive * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastrointestinal disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastrointestinal haemorrhage * 1  2/597 (0.34%)  4/587 (0.68%) 
Gastrointestinal hypomotility * 1  1/597 (0.17%)  0/587 (0.00%) 
Gastrointestinal motility disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Gastrointestinal perforation * 1  0/597 (0.00%)  1/587 (0.17%) 
Gastrooesophageal reflux disease * 1  1/597 (0.17%)  2/587 (0.34%) 
Gingival bleeding * 1  0/597 (0.00%)  1/587 (0.17%) 
Glossodynia * 1  1/597 (0.17%)  0/587 (0.00%) 
Haemorrhoids * 1  2/597 (0.34%)  2/587 (0.34%) 
Ileus * 1  5/597 (0.84%)  3/587 (0.51%) 
Ileus paralytic * 1  3/597 (0.50%)  0/587 (0.00%) 
Impaired gastric emptying * 1  0/597 (0.00%)  1/587 (0.17%) 
Lip ulceration * 1  1/597 (0.17%)  0/587 (0.00%) 
Lower gastrointestinal haemorrhage * 1  1/597 (0.17%)  0/587 (0.00%) 
Mouth haemorrhage * 1  1/597 (0.17%)  0/587 (0.00%) 
Mouth ulceration * 1  0/597 (0.00%)  1/587 (0.17%) 
Nausea * 1  22/597 (3.69%)  29/587 (4.94%) 
Oesophagitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Oral disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Oral pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Pancreatitis * 1  3/597 (0.50%)  1/587 (0.17%) 
Peptic ulcer * 1  1/597 (0.17%)  0/587 (0.00%) 
Perianal erythema * 1  0/597 (0.00%)  1/587 (0.17%) 
Peritonitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Regurgitation * 1  0/597 (0.00%)  1/587 (0.17%) 
Stomatitis * 1  1/597 (0.17%)  1/587 (0.17%) 
Swollen tongue * 1  0/597 (0.00%)  1/587 (0.17%) 
Tongue ulceration * 1  0/597 (0.00%)  1/587 (0.17%) 
Tooth loss * 1  1/597 (0.17%)  0/587 (0.00%) 
Upper gastrointestinal haemorrhage * 1  1/597 (0.17%)  1/587 (0.17%) 
Vomiting * 1  14/597 (2.35%)  14/587 (2.39%) 
General disorders     
Asthenia * 1  1/597 (0.17%)  4/587 (0.68%) 
Catheter site erythema * 1  0/597 (0.00%)  1/587 (0.17%) 
Catheter site haematoma * 1  0/597 (0.00%)  1/587 (0.17%) 
Catheter site haemorrhage * 1  1/597 (0.17%)  1/587 (0.17%) 
Catheter site pain * 1  0/597 (0.00%)  3/587 (0.51%) 
Chest pain * 1  0/597 (0.00%)  1/587 (0.17%) 
Chills * 1  0/597 (0.00%)  3/587 (0.51%) 
Device malfunction * 1  0/597 (0.00%)  1/587 (0.17%) 
Device occlusion * 1  3/597 (0.50%)  5/587 (0.85%) 
Face oedema * 1  0/597 (0.00%)  1/587 (0.17%) 
Generalised oedema * 1  11/597 (1.84%)  4/587 (0.68%) 
Hyperthermia * 1  2/597 (0.34%)  0/587 (0.00%) 
Hypothermia * 1  0/597 (0.00%)  6/587 (1.02%) 
Implant site effusion * 1  1/597 (0.17%)  0/587 (0.00%) 
Infusion site erythema * 1  1/597 (0.17%)  0/587 (0.00%) 
Infusion site extravasation * 1  1/597 (0.17%)  2/587 (0.34%) 
Infusion site oedema * 1  1/597 (0.17%)  0/587 (0.00%) 
Infusion site phlebitis * 1  3/597 (0.50%)  5/587 (0.85%) 
Infusion site swelling * 1  0/597 (0.00%)  1/587 (0.17%) 
Infusion site thrombosis * 1  2/597 (0.34%)  0/587 (0.00%) 
Irritability * 1  0/597 (0.00%)  1/587 (0.17%) 
Localised oedema * 1  0/597 (0.00%)  2/587 (0.34%) 
Medical device complication * 1  1/597 (0.17%)  0/587 (0.00%) 
Medical device pain * 1  1/597 (0.17%)  1/587 (0.17%) 
Multi-organ disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Non-cardiac chest pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Oedema * 1  3/597 (0.50%)  2/587 (0.34%) 
Oedema peripheral * 1  12/597 (2.01%)  13/587 (2.21%) 
Pain * 1  10/597 (1.68%)  5/587 (0.85%) 
Puncture site haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Pyrexia * 1  22/597 (3.69%)  24/587 (4.09%) 
Systemic inflammatory response syndrome * 1  1/597 (0.17%)  0/587 (0.00%) 
Thrombosis in device * 1  1/597 (0.17%)  1/587 (0.17%) 
Vessel puncture site haematoma * 1  0/597 (0.00%)  1/587 (0.17%) 
Vessel puncture site pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Xerosis * 1  1/597 (0.17%)  0/587 (0.00%) 
Drug withdrawal syndrome * 1  2/597 (0.34%)  0/587 (0.00%) 
Hepatobiliary disorders     
Biliary fistula * 1  0/597 (0.00%)  1/587 (0.17%) 
Cholangitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Cholecystitis * 1  2/597 (0.34%)  1/587 (0.17%) 
Cholestasis * 1  2/597 (0.34%)  1/587 (0.17%) 
Cytolytic hepatitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Hepatic cirrhosis * 1  1/597 (0.17%)  0/587 (0.00%) 
Hepatic failure * 1  0/597 (0.00%)  1/587 (0.17%) 
Hepatitis toxic * 1  0/597 (0.00%)  1/587 (0.17%) 
Hepatobiliary disease * 1  0/597 (0.00%)  1/587 (0.17%) 
Hyperbilirubinaemia * 1  1/597 (0.17%)  2/587 (0.34%) 
Jaundice * 1  1/597 (0.17%)  0/587 (0.00%) 
Immune system disorders     
Drug hypersensitivity * 1  0/597 (0.00%)  1/587 (0.17%) 
Infections and infestations     
Abdominal abscess * 1  0/597 (0.00%)  1/587 (0.17%) 
Abdominal infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Abscess limb * 1  1/597 (0.17%)  0/587 (0.00%) 
Acinetobacter infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Bacteraemia * 1  4/597 (0.67%)  4/587 (0.68%) 
Bacterial disease carrier * 1  0/597 (0.00%)  1/587 (0.17%) 
Bacterial infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Bacteriuria * 1  0/597 (0.00%)  1/587 (0.17%) 
Bronchitis * 1  1/597 (0.17%)  1/587 (0.17%) 
Bronchitis bacterial * 1  0/597 (0.00%)  1/587 (0.17%) 
Candida sepsis * 1  1/597 (0.17%)  1/587 (0.17%) 
Candidiasis * 1  4/597 (0.67%)  5/587 (0.85%) 
Candiduria * 1  0/597 (0.00%)  1/587 (0.17%) 
Catheter site infection * 1  0/597 (0.00%)  3/587 (0.51%) 
Cellulitis * 1  4/597 (0.67%)  2/587 (0.34%) 
Citrobacter infection * 1  2/597 (0.34%)  0/587 (0.00%) 
Clostridial infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Clostridium difficile colitis * 1  7/597 (1.17%)  6/587 (1.02%) 
Conjunctivitis bacterial * 1  0/597 (0.00%)  1/587 (0.17%) 
Cystitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Device related infection * 1  3/597 (0.50%)  2/587 (0.34%) 
Device related sepsis * 1  0/597 (0.00%)  2/587 (0.34%) 
Enterobacter bacteraemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Enterobacter pneumonia * 1  0/597 (0.00%)  1/587 (0.17%) 
Enterococcal bacteraemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Enterococcal infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Escherichia urinary tract infection * 1  2/597 (0.34%)  0/587 (0.00%) 
Fungal cystitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Fungal infection * 1  6/597 (1.01%)  5/587 (0.85%) 
Fungal sepsis * 1  1/597 (0.17%)  0/587 (0.00%) 
Fungal skin infection * 1  6/597 (1.01%)  8/587 (1.36%) 
Gastrointestinal infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Genital infection fungal * 1  0/597 (0.00%)  1/587 (0.17%) 
Herpes simplex * 1  0/597 (0.00%)  1/587 (0.17%) 
Herpes zoster * 1  0/597 (0.00%)  1/587 (0.17%) 
Infectious disease carrier * 1  2/597 (0.34%)  0/587 (0.00%) 
Influenza * 1  0/597 (0.00%)  1/587 (0.17%) 
Infusion site cellulitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Infusion site infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Kidney infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Klebsiella bacteraemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Klebsiella infection * 1  1/597 (0.17%)  2/587 (0.34%) 
Lung abscess * 1  1/597 (0.17%)  1/587 (0.17%) 
Lung infection * 1  5/597 (0.84%)  0/587 (0.00%) 
Lung infection pseudomonal * 1  6/597 (1.01%)  4/587 (0.68%) 
Mastitis fungal * 1  0/597 (0.00%)  1/587 (0.17%) 
Meningitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Nasopharyngitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Oesophageal candidiasis * 1  1/597 (0.17%)  0/587 (0.00%) 
Oral candidiasis * 1  6/597 (1.01%)  5/587 (0.85%) 
Oral fungal infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Oral herpes * 1  1/597 (0.17%)  3/587 (0.51%) 
Osteomyelitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Pancreatic abscess * 1  1/597 (0.17%)  0/587 (0.00%) 
Pelvic abscess * 1  0/597 (0.00%)  1/587 (0.17%) 
Pleural infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Pneumonia * 1  3/597 (0.50%)  11/587 (1.87%) 
Pneumonia bacterial * 1  4/597 (0.67%)  5/587 (0.85%) 
Pneumonia escherichia * 1  1/597 (0.17%)  0/587 (0.00%) 
Pneumonia fungal * 1  1/597 (0.17%)  0/587 (0.00%) 
Pneumonia klebsiella * 1  2/597 (0.34%)  3/587 (0.51%) 
Pneumonia staphylococcal * 1  1/597 (0.17%)  1/587 (0.17%) 
Pneumonia streptococcal * 1  1/597 (0.17%)  0/587 (0.00%) 
Postoperative abscess * 1  0/597 (0.00%)  3/587 (0.51%) 
Postoperative wound infection * 1  3/597 (0.50%)  1/587 (0.17%) 
Pseudomembranous colitis * 1  1/597 (0.17%)  1/587 (0.17%) 
Pseudomonas infection * 1  0/597 (0.00%)  3/587 (0.51%) 
Rash pustular * 1  0/597 (0.00%)  1/587 (0.17%) 
Respiratory moniliasis * 1  0/597 (0.00%)  1/587 (0.17%) 
Respiratory tract infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Respiratory tract infection bacterial * 1  1/597 (0.17%)  0/587 (0.00%) 
Sepsis * 1  3/597 (0.50%)  2/587 (0.34%) 
Septic shock * 1  1/597 (0.17%)  3/587 (0.51%) 
Sinusitis * 1  1/597 (0.17%)  1/587 (0.17%) 
Skin candida * 1  1/597 (0.17%)  4/587 (0.68%) 
Skin infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Staphylococcal bacteraemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Staphylococcal infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Stenotrophomonas infection * 1  1/597 (0.17%)  0/587 (0.00%) 
Systemic candida * 1  1/597 (0.17%)  0/587 (0.00%) 
Tinea pedis * 1  1/597 (0.17%)  1/587 (0.17%) 
Tracheitis * 1  1/597 (0.17%)  0/587 (0.00%) 
Tracheobronchitis * 1  2/597 (0.34%)  2/587 (0.34%) 
Tracheostomy infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Upper respiratory tract infection * 1  0/597 (0.00%)  1/587 (0.17%) 
Urinary tract infection * 1  29/597 (4.86%)  19/587 (3.24%) 
Urinary tract infection fungal * 1  3/597 (0.50%)  5/587 (0.85%) 
Urinary tract infection pseudomonal * 1  3/597 (0.50%)  2/587 (0.34%) 
Vulvovaginal candidiasis * 1  2/597 (0.34%)  1/587 (0.17%) 
Vulvovaginal mycotic infection * 1  1/597 (0.17%)  1/587 (0.17%) 
Wound infection * 1  0/597 (0.00%)  2/587 (0.34%) 
Wound infection bacterial * 1  1/597 (0.17%)  0/587 (0.00%) 
Wound infection fungal * 1  1/597 (0.17%)  0/587 (0.00%) 
Injury, poisoning and procedural complications     
Anaemia postoperative * 1  0/597 (0.00%)  1/587 (0.17%) 
Anal injury * 1  1/597 (0.17%)  0/587 (0.00%) 
Contusion * 1  4/597 (0.67%)  2/587 (0.34%) 
Endotracheal intubation complication * 1  1/597 (0.17%)  2/587 (0.34%) 
Eschar * 1  2/597 (0.34%)  0/587 (0.00%) 
Excoriation * 1  3/597 (0.50%)  5/587 (0.85%) 
Fall * 1  1/597 (0.17%)  1/587 (0.17%) 
Feeding tube complication * 1  2/597 (0.34%)  1/587 (0.17%) 
Foreign body * 1  1/597 (0.17%)  0/587 (0.00%) 
Haematuria traumatic * 1  1/597 (0.17%)  2/587 (0.34%) 
Hepatic haematoma * 1  0/597 (0.00%)  1/587 (0.17%) 
Intentional overdose * 1  1/597 (0.17%)  0/587 (0.00%) 
Joint dislocation * 1  0/597 (0.00%)  1/587 (0.17%) 
Joint injury * 1  0/597 (0.00%)  1/587 (0.17%) 
Mechanical ventilation complication * 1  0/597 (0.00%)  1/587 (0.17%) 
Mouth injury * 1  0/597 (0.00%)  1/587 (0.17%) 
Pneumothorax traumatic * 1  1/597 (0.17%)  2/587 (0.34%) 
Post concussion syndrome * 1  0/597 (0.00%)  1/587 (0.17%) 
Post procedural complication * 1  0/597 (0.00%)  1/587 (0.17%) 
Post procedural discharge * 1  0/597 (0.00%)  1/587 (0.17%) 
Post procedural fistula * 1  2/597 (0.34%)  1/587 (0.17%) 
Post procedural haematoma * 1  1/597 (0.17%)  0/587 (0.00%) 
Post procedural haematuria * 1  0/597 (0.00%)  2/587 (0.34%) 
Post procedural haemorrhage * 1  4/597 (0.67%)  6/587 (1.02%) 
Post procedural oedema * 1  2/597 (0.34%)  2/587 (0.34%) 
Post-thoracotomy pain syndrome * 1  1/597 (0.17%)  0/587 (0.00%) 
Postoperative wound complication * 1  1/597 (0.17%)  0/587 (0.00%) 
Procedural pain * 1  6/597 (1.01%)  5/587 (0.85%) 
Pulmonary radiation injury * 1  1/597 (0.17%)  0/587 (0.00%) 
Rib fracture * 1  1/597 (0.17%)  0/587 (0.00%) 
Skin injury * 1  0/597 (0.00%)  1/587 (0.17%) 
Skin laceration * 1  5/597 (0.84%)  4/587 (0.68%) 
Subdural haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Tendon rupture * 1  1/597 (0.17%)  0/587 (0.00%) 
Therapeutic agent toxicity * 1  1/597 (0.17%)  0/587 (0.00%) 
Tracheal obstruction * 1  0/597 (0.00%)  1/587 (0.17%) 
Tracheostomy malfunction * 1  1/597 (0.17%)  0/587 (0.00%) 
Transfusion reaction * 1  1/597 (0.17%)  0/587 (0.00%) 
Wound dehiscence * 1  1/597 (0.17%)  1/587 (0.17%) 
Investigations     
Acid base balance abnormal * 1  1/597 (0.17%)  0/587 (0.00%) 
Alanine aminotransferase increased * 1  4/597 (0.67%)  3/587 (0.51%) 
Antibiotic resistant Staphylococcus test positive * 1  1/597 (0.17%)  1/587 (0.17%) 
Aspartate aminotransferase increased * 1  5/597 (0.84%)  3/587 (0.51%) 
Bacterial test positive * 1  2/597 (0.34%)  4/587 (0.68%) 
Blood albumin decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood alkaline phosphatase increased * 1  2/597 (0.34%)  1/587 (0.17%) 
Blood amylase increased * 1  1/597 (0.17%)  4/587 (0.68%) 
Blood bicarbonate decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood bilirubin increased * 1  3/597 (0.50%)  1/587 (0.17%) 
Blood calcium decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood chloride decreased * 1  1/597 (0.17%)  0/587 (0.00%) 
Blood creatinine increased * 1  2/597 (0.34%)  4/587 (0.68%) 
Blood culture positive * 1  1/597 (0.17%)  0/587 (0.00%) 
Blood glucose decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood glucose increased * 1  1/597 (0.17%)  0/587 (0.00%) 
Blood lactate dehydrogenase increased * 1  4/597 (0.67%)  4/587 (0.68%) 
Blood magnesium decreased * 1  0/597 (0.00%)  2/587 (0.34%) 
Blood phosphorus decreased * 1  1/597 (0.17%)  2/587 (0.34%) 
Blood potassium decreased * 1  1/597 (0.17%)  0/587 (0.00%) 
Blood pressure decreased * 1  1/597 (0.17%)  1/587 (0.17%) 
Blood pressure increased * 1  3/597 (0.50%)  3/587 (0.51%) 
Blood sodium decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood triglycerides increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood urea increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Blood urine present * 1  0/597 (0.00%)  1/587 (0.17%) 
Body temperature increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Carbon dioxide increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Cardiac enzymes increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Chest X-ray abnormal * 1  0/597 (0.00%)  1/587 (0.17%) 
Clostridium test * 1  1/597 (0.17%)  0/587 (0.00%) 
Coagulation time prolonged * 1  0/597 (0.00%)  1/587 (0.17%) 
Fungal test positive * 1  4/597 (0.67%)  2/587 (0.34%) 
Gastric occult blood positive * 1  1/597 (0.17%)  0/587 (0.00%) 
Haematocrit decreased * 1  1/597 (0.17%)  1/587 (0.17%) 
Haemoglobin decreased * 1  2/597 (0.34%)  3/587 (0.51%) 
Heart rate increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Hepatic enzyme increased * 1  3/597 (0.50%)  5/587 (0.85%) 
Lipase increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Liver function test abnormal * 1  4/597 (0.67%)  1/587 (0.17%) 
Neutrophil count increased * 1  1/597 (0.17%)  0/587 (0.00%) 
Occult blood positive * 1  2/597 (0.34%)  1/587 (0.17%) 
Oxygen saturation decreased * 1  1/597 (0.17%)  2/587 (0.34%) 
Pedal pulse decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Platelet count decreased * 1  2/597 (0.34%)  0/587 (0.00%) 
Platelet count increased * 1  4/597 (0.67%)  1/587 (0.17%) 
Prothrombin level decreased * 1  1/597 (0.17%)  0/587 (0.00%) 
Prothrombin time prolonged * 1  0/597 (0.00%)  2/587 (0.34%) 
Pulse abnormal * 1  0/597 (0.00%)  1/587 (0.17%) 
Radial pulse decreased * 1  0/597 (0.00%)  1/587 (0.17%) 
Red blood cell count decreased * 1  1/597 (0.17%)  0/587 (0.00%) 
Reticulocyte count increased * 1  1/597 (0.17%)  1/587 (0.17%) 
Spirometry abnormal * 1  1/597 (0.17%)  0/587 (0.00%) 
Transaminases increased * 1  3/597 (0.50%)  5/587 (0.85%) 
Troponin increased * 1  2/597 (0.34%)  0/587 (0.00%) 
Urine output decreased * 1  0/597 (0.00%)  2/587 (0.34%) 
Urine sodium increased * 1  0/597 (0.00%)  1/587 (0.17%) 
Weight decreased * 1  2/597 (0.34%)  0/587 (0.00%) 
White blood cell count increased * 1  1/597 (0.17%)  1/587 (0.17%) 
Influenza virus test positive * 1  0/597 (0.00%)  1/587 (0.17%) 
Metabolism and nutrition disorders     
Acidosis * 1  0/597 (0.00%)  1/587 (0.17%) 
Cell death * 1  1/597 (0.17%)  0/587 (0.00%) 
Decreased appetite * 1  0/597 (0.00%)  2/587 (0.34%) 
Dehydration * 1  3/597 (0.50%)  3/587 (0.51%) 
Diabetes mellitus * 1  2/597 (0.34%)  2/587 (0.34%) 
Electrolyte depletion * 1  1/597 (0.17%)  0/587 (0.00%) 
Electrolyte imbalance * 1  1/597 (0.17%)  6/587 (1.02%) 
Fluid overload * 1  10/597 (1.68%)  11/587 (1.87%) 
Hypercalcaemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Hypercreatininaemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Hyperglycaemia * 1  10/597 (1.68%)  18/587 (3.07%) 
Hyperkalaemia * 1  8/597 (1.34%)  12/587 (2.04%) 
Hyperlactacidaemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Hypermagnesaemia * 1  0/597 (0.00%)  3/587 (0.51%) 
Hypernatraemia * 1  7/597 (1.17%)  8/587 (1.36%) 
Hyperphosphataemia * 1  2/597 (0.34%)  1/587 (0.17%) 
Hypervolaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Hypoalbuminaemia * 1  3/597 (0.50%)  8/587 (1.36%) 
Hypocalcaemia * 1  9/597 (1.51%)  7/587 (1.19%) 
Hypochloraemia * 1  1/597 (0.17%)  1/587 (0.17%) 
Hypoglycaemia * 1  21/597 (3.52%)  13/587 (2.21%) 
Hypokalaemia * 1  44/597 (7.37%)  43/587 (7.33%) 
Hypomagnesaemia * 1  16/597 (2.68%)  15/587 (2.56%) 
Hyponatraemia * 1  12/597 (2.01%)  13/587 (2.21%) 
Hypophosphataemia * 1  11/597 (1.84%)  11/587 (1.87%) 
Hypovolaemia * 1  3/597 (0.50%)  1/587 (0.17%) 
Iron overload * 1  1/597 (0.17%)  0/587 (0.00%) 
Malnutrition * 1  4/597 (0.67%)  3/587 (0.51%) 
Metabolic acidosis * 1  4/597 (0.67%)  4/587 (0.68%) 
Metabolic alkalosis * 1  6/597 (1.01%)  8/587 (1.36%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/597 (0.17%)  1/587 (0.17%) 
Back pain * 1  1/597 (0.17%)  4/587 (0.68%) 
Bone disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Flank pain * 1  0/597 (0.00%)  1/587 (0.17%) 
Muscle rigidity * 1  1/597 (0.17%)  2/587 (0.34%) 
Muscle twitching * 1  0/597 (0.00%)  1/587 (0.17%) 
Muscular weakness * 1  0/597 (0.00%)  1/587 (0.17%) 
Musculoskeletal chest pain * 1  1/597 (0.17%)  1/587 (0.17%) 
Musculoskeletal disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Musculoskeletal stiffness * 1  1/597 (0.17%)  0/587 (0.00%) 
Neck pain * 1  0/597 (0.00%)  1/587 (0.17%) 
Pain in extremity * 1  5/597 (0.84%)  1/587 (0.17%) 
Rhabdomyolysis * 1  0/597 (0.00%)  1/587 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  1/597 (0.17%)  0/587 (0.00%) 
Lymphoma * 1  0/597 (0.00%)  1/587 (0.17%) 
Renal neoplasm * 1  1/597 (0.17%)  0/587 (0.00%) 
Tumour pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Nervous system disorders     
Aphasia * 1  0/597 (0.00%)  1/587 (0.17%) 
Aphonia * 1  1/597 (0.17%)  0/587 (0.00%) 
Autonomic nervous system imbalance * 1  1/597 (0.17%)  0/587 (0.00%) 
Brain oedema * 1  1/597 (0.17%)  0/587 (0.00%) 
Cerebral ischaemia * 1  1/597 (0.17%)  0/587 (0.00%) 
Coma * 1  1/597 (0.17%)  0/587 (0.00%) 
Convulsion * 1  3/597 (0.50%)  3/587 (0.51%) 
Convulsions local * 1  1/597 (0.17%)  0/587 (0.00%) 
Depressed level of consciousness * 1  1/597 (0.17%)  0/587 (0.00%) 
Dizziness * 1  2/597 (0.34%)  1/587 (0.17%) 
Encephalopathy * 1  2/597 (0.34%)  1/587 (0.17%) 
Epilepsy * 1  1/597 (0.17%)  0/587 (0.00%) 
Haemorrhage intracranial * 1  0/597 (0.00%)  1/587 (0.17%) 
Headache * 1  7/597 (1.17%)  8/587 (1.36%) 
Hemiparesis * 1  1/597 (0.17%)  0/587 (0.00%) 
Hydrocephalus * 1  1/597 (0.17%)  1/587 (0.17%) 
Hypoaesthesia * 1  0/597 (0.00%)  1/587 (0.17%) 
Intracranial pressure increased * 1  0/597 (0.00%)  2/587 (0.34%) 
Intraventricular haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Ischaemic stroke * 1  1/597 (0.17%)  0/587 (0.00%) 
Lethargy * 1  1/597 (0.17%)  3/587 (0.51%) 
Mental impairment * 1  2/597 (0.34%)  0/587 (0.00%) 
Metabolic encephalopathy * 1  1/597 (0.17%)  1/587 (0.17%) 
Muscle spasticity * 1  0/597 (0.00%)  1/587 (0.17%) 
Myoclonus * 1  1/597 (0.17%)  0/587 (0.00%) 
Neuromuscular blockade * 1  1/597 (0.17%)  0/587 (0.00%) 
Paraesthesia * 1  0/597 (0.00%)  1/587 (0.17%) 
Paralysis flaccid * 1  0/597 (0.00%)  1/587 (0.17%) 
Presyncope * 1  2/597 (0.34%)  0/587 (0.00%) 
Psychomotor hyperactivity * 1  0/597 (0.00%)  1/587 (0.17%) 
Radial nerve palsy * 1  0/597 (0.00%)  1/587 (0.17%) 
Sedation * 1  1/597 (0.17%)  1/587 (0.17%) 
Somnolence * 1  3/597 (0.50%)  1/587 (0.17%) 
Syncope * 1  0/597 (0.00%)  1/587 (0.17%) 
Tension headache * 1  0/597 (0.00%)  1/587 (0.17%) 
Tremor * 1  0/597 (0.00%)  3/587 (0.51%) 
Unresponsive to stimuli * 1  1/597 (0.17%)  0/587 (0.00%) 
Psychiatric disorders     
Affective disorder * 1  1/597 (0.17%)  0/587 (0.00%) 
Agitation * 1  13/597 (2.18%)  22/587 (3.75%) 
Anxiety * 1  11/597 (1.84%)  15/587 (2.56%) 
Confusional state * 1  5/597 (0.84%)  1/587 (0.17%) 
Delirium * 1  4/597 (0.67%)  2/587 (0.34%) 
Depression * 1  12/597 (2.01%)  7/587 (1.19%) 
Disorientation * 1  3/597 (0.50%)  0/587 (0.00%) 
Hallucination * 1  2/597 (0.34%)  1/587 (0.17%) 
Insomnia * 1  14/597 (2.35%)  18/587 (3.07%) 
Mental status changes * 1  1/597 (0.17%)  3/587 (0.51%) 
Post-traumatic stress disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Psychotic disorder * 1  2/597 (0.34%)  2/587 (0.34%) 
Restlessness * 1  5/597 (0.84%)  3/587 (0.51%) 
Renal and urinary disorders     
Acute prerenal failure * 1  1/597 (0.17%)  0/587 (0.00%) 
Azotaemia * 1  1/597 (0.17%)  5/587 (0.85%) 
Chromaturia * 1  1/597 (0.17%)  2/587 (0.34%) 
Haematuria * 1  3/597 (0.50%)  4/587 (0.68%) 
Nephrolithiasis * 1  0/597 (0.00%)  1/587 (0.17%) 
Nephropathy toxic * 1  0/597 (0.00%)  1/587 (0.17%) 
Oliguria * 1  6/597 (1.01%)  3/587 (0.51%) 
Pollakiuria * 1  1/597 (0.17%)  0/587 (0.00%) 
Proteinuria * 1  1/597 (0.17%)  0/587 (0.00%) 
Pyuria * 1  1/597 (0.17%)  0/587 (0.00%) 
Renal failure * 1  2/597 (0.34%)  8/587 (1.36%) 
Renal failure acute * 1  5/597 (0.84%)  9/587 (1.53%) 
Renal failure chronic * 1  0/597 (0.00%)  1/587 (0.17%) 
Renal impairment * 1  3/597 (0.50%)  3/587 (0.51%) 
Urethral pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Urinary retention * 1  3/597 (0.50%)  1/587 (0.17%) 
Reproductive system and breast disorders     
Genital rash * 1  2/597 (0.34%)  0/587 (0.00%) 
Metrorrhagia * 1  1/597 (0.17%)  0/587 (0.00%) 
Oedema genital * 1  0/597 (0.00%)  1/587 (0.17%) 
Penile discharge * 1  1/597 (0.17%)  0/587 (0.00%) 
Penile swelling * 1  0/597 (0.00%)  1/587 (0.17%) 
Prostatism * 1  0/597 (0.00%)  1/587 (0.17%) 
Scrotal oedema * 1  1/597 (0.17%)  3/587 (0.51%) 
Scrotal swelling * 1  0/597 (0.00%)  1/587 (0.17%) 
Testicular torsion * 1  1/597 (0.17%)  0/587 (0.00%) 
Vulvovaginal burning sensation * 1  1/597 (0.17%)  0/587 (0.00%) 
Vulvovaginal pruritus * 1  1/597 (0.17%)  0/587 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute lung injury * 1  1/597 (0.17%)  0/587 (0.00%) 
Acute respiratory distress syndrome * 1  4/597 (0.67%)  3/587 (0.51%) 
Aspiration * 1  1/597 (0.17%)  3/587 (0.51%) 
Asthma * 1  2/597 (0.34%)  0/587 (0.00%) 
Atelectasis * 1  3/597 (0.50%)  1/587 (0.17%) 
Bronchial obstruction * 1  0/597 (0.00%)  2/587 (0.34%) 
Bronchial secretion retention * 1  1/597 (0.17%)  1/587 (0.17%) 
Bronchospasm * 1  4/597 (0.67%)  4/587 (0.68%) 
Chronic obstructive pulmonary disease * 1  2/597 (0.34%)  1/587 (0.17%) 
Cough * 1  1/597 (0.17%)  1/587 (0.17%) 
Dependence on respirator * 1  1/597 (0.17%)  2/587 (0.34%) 
Dysphonia * 1  2/597 (0.34%)  0/587 (0.00%) 
Dyspnoea * 1  1/597 (0.17%)  6/587 (1.02%) 
Epistaxis * 1  0/597 (0.00%)  5/587 (0.85%) 
Haemoptysis * 1  6/597 (1.01%)  4/587 (0.68%) 
Hiccups * 1  3/597 (0.50%)  2/587 (0.34%) 
Hydrothorax * 1  1/597 (0.17%)  0/587 (0.00%) 
Hypercapnia * 1  0/597 (0.00%)  1/587 (0.17%) 
Hypoxia * 1  4/597 (0.67%)  3/587 (0.51%) 
Increased bronchial secretion * 1  2/597 (0.34%)  0/587 (0.00%) 
Laryngeal oedema * 1  4/597 (0.67%)  1/587 (0.17%) 
Lung consolidation * 1  1/597 (0.17%)  0/587 (0.00%) 
Lung disorder * 1  0/597 (0.00%)  2/587 (0.34%) 
Nasal congestion * 1  1/597 (0.17%)  1/587 (0.17%) 
Obstructive airways disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Oropharyngeal pain * 1  4/597 (0.67%)  0/587 (0.00%) 
Pleural effusion * 1  6/597 (1.01%)  10/587 (1.70%) 
Pleuritic pain * 1  1/597 (0.17%)  0/587 (0.00%) 
Pleurocutaneous fistula * 1  0/597 (0.00%)  1/587 (0.17%) 
Pneumomediastinum * 1  0/597 (0.00%)  1/587 (0.17%) 
Pneumonia aspiration * 1  2/597 (0.34%)  0/587 (0.00%) 
Pneumothorax * 1  0/597 (0.00%)  4/587 (0.68%) 
Pneumothorax spontaneous tension * 1  0/597 (0.00%)  1/587 (0.17%) 
Pulmonary alveolar haemorrhage * 1  0/597 (0.00%)  1/587 (0.17%) 
Pulmonary hypertension * 1  0/597 (0.00%)  1/587 (0.17%) 
Pulmonary oedema * 1  5/597 (0.84%)  4/587 (0.68%) 
Pulmonary vascular disorder * 1  0/597 (0.00%)  1/587 (0.17%) 
Respiratory acidosis * 1  1/597 (0.17%)  2/587 (0.34%) 
Respiratory alkalosis * 1  2/597 (0.34%)  1/587 (0.17%) 
Respiratory arrest * 1  1/597 (0.17%)  0/587 (0.00%) 
Respiratory distress * 1  0/597 (0.00%)  3/587 (0.51%) 
Respiratory failure * 1  6/597 (1.01%)  7/587 (1.19%) 
Rhinorrhoea * 1  0/597 (0.00%)  1/587 (0.17%) 
Sinus congestion * 1  0/597 (0.00%)  1/587 (0.17%) 
Tachypnoea * 1  3/597 (0.50%)  1/587 (0.17%) 
Wheezing * 1  0/597 (0.00%)  3/587 (0.51%) 
Skin and subcutaneous tissue disorders     
Blister * 1  2/597 (0.34%)  2/587 (0.34%) 
Decubitus ulcer * 1  16/597 (2.68%)  23/587 (3.92%) 
Dermatitis * 1  3/597 (0.50%)  1/587 (0.17%) 
Dermatitis allergic * 1  0/597 (0.00%)  2/587 (0.34%) 
Dermatitis bullous * 1  1/597 (0.17%)  0/587 (0.00%) 
Dermatitis contact * 1  0/597 (0.00%)  2/587 (0.34%) 
Dermatitis diaper * 1  1/597 (0.17%)  0/587 (0.00%) 
Dermatosis * 1  0/597 (0.00%)  1/587 (0.17%) 
Drug eruption * 1  2/597 (0.34%)  2/587 (0.34%) 
Dry skin * 1  2/597 (0.34%)  1/587 (0.17%) 
Ecchymosis * 1  0/597 (0.00%)  2/587 (0.34%) 
Eczema * 1  1/597 (0.17%)  0/587 (0.00%) 
Erythema * 1  3/597 (0.50%)  4/587 (0.68%) 
Exfoliative rash * 1  1/597 (0.17%)  0/587 (0.00%) 
Hyperhidrosis * 1  1/597 (0.17%)  1/587 (0.17%) 
Intertrigo * 1  1/597 (0.17%)  1/587 (0.17%) 
Leukocytoclastic vasculitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Penile ulceration * 1  0/597 (0.00%)  1/587 (0.17%) 
Plantar erythema * 1  0/597 (0.00%)  1/587 (0.17%) 
Pruritus * 1  5/597 (0.84%)  3/587 (0.51%) 
Pruritus generalised * 1  1/597 (0.17%)  1/587 (0.17%) 
Rash * 1  22/597 (3.69%)  20/587 (3.41%) 
Rash erythematous * 1  1/597 (0.17%)  1/587 (0.17%) 
Rash generalised * 1  1/597 (0.17%)  0/587 (0.00%) 
Rash macular * 1  0/597 (0.00%)  2/587 (0.34%) 
Rash maculo-papular * 1  0/597 (0.00%)  1/587 (0.17%) 
Rash papulosquamous * 1  1/597 (0.17%)  0/587 (0.00%) 
Red man syndrome * 1  0/597 (0.00%)  1/587 (0.17%) 
Skin discolouration * 1  1/597 (0.17%)  1/587 (0.17%) 
Skin disorder * 1  4/597 (0.67%)  0/587 (0.00%) 
Skin erosion * 1  0/597 (0.00%)  1/587 (0.17%) 
Skin irritation * 1  0/597 (0.00%)  1/587 (0.17%) 
Skin lesion * 1  2/597 (0.34%)  2/587 (0.34%) 
Skin maceration * 1  0/597 (0.00%)  1/587 (0.17%) 
Skin ulcer * 1  6/597 (1.01%)  4/587 (0.68%) 
Subcutaneous emphysema * 1  0/597 (0.00%)  2/587 (0.34%) 
Urticaria * 1  1/597 (0.17%)  0/587 (0.00%) 
Papule * 1  0/597 (0.00%)  1/587 (0.17%) 
Vascular disorders     
Deep vein thrombosis * 1  1/597 (0.17%)  6/587 (1.02%) 
Flushing * 1  0/597 (0.00%)  1/587 (0.17%) 
Haemorrhage * 1  1/597 (0.17%)  0/587 (0.00%) 
Hyperaemia * 1  0/597 (0.00%)  1/587 (0.17%) 
Hypertension * 1  28/597 (4.69%)  33/587 (5.62%) 
Hypertensive crisis * 1  1/597 (0.17%)  1/587 (0.17%) 
Hypotension * 1  21/597 (3.52%)  35/587 (5.96%) 
Phlebitis * 1  0/597 (0.00%)  1/587 (0.17%) 
Venous thrombosis * 1  0/597 (0.00%)  1/587 (0.17%) 
Venous thrombosis limb * 1  0/597 (0.00%)  1/587 (0.17%) 
Embolism arterial * 1  1/597 (0.17%)  0/587 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
EOS visit window of 15-21 days after last dose as specified in protocol was expanded during blinded evaluability assessments and prior to database lock and unblinding to 7-30 days after last dose in order to better fit the actual study visit days.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00084266     History of Changes
Other Study ID Numbers: A5951001
First Submitted: June 9, 2004
First Posted: June 11, 2004
Results First Submitted: March 10, 2011
Results First Posted: May 9, 2011
Last Update Posted: February 1, 2012