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| ID | Type | Description | Link |
|---|---|---|---|
| B1811054 | Other Identifier | Pfizer |
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To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tigecycline | Drug | The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical and Microbiological Cure: All Participants | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
| Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
| Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) |
| Percentage of Participants With Composite Cure: All Participants | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
| Percentage of Participants With Composite Cure: Nosocomial Infections | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Probable Failure at Follow-up | Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. | Follow-up (up to Day 47) |
| Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (i.e., at least 18 years old) with a verified diagnosis of complicated Intra-Abdominal Infection (cIAI) or complicated Skin and Skin Structure Infection (cSSSI), for whom the decision for Tygacil treatment had already been made.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23772047 | Derived | Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140. | |
| 23772045 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
A total of 1,028 participants were documented at 137 observational sites. Three participants were excluded from analysis due to retrospective documentation.
Non-interventional study; participants were selected and treated according to the usual clinical practice of their physician.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tygacil | Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tygacil | Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Clinical and Microbiological Cure: All Participants | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | All participants: participants exposed to Tygacil who had non-retrospective post-baseline data. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
|
Not provided
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tygacil | Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Percentage of Participants With Composite Cure: Community-acquired Infections | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) |
Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. |
| Follow-up (up to Day 47) |
| Antibiotic Agents Chosen for Combination Therapy With Tigecycline | Percentage of participants who received each antibiotic administered as combination therapy with tigecycline. | Baseline to End of Treatment (up to Day 47) |
| Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Reasons for change in antibiotic treatment from Tygacil to another antibiotic. | Baseline to End of Treatment (up to Day 47) |
| Reasons for Utilization of Tygacil | Baseline to End of Treatment (up to Day 47) |
| Overall Mortality: All Participants | Deaths for any reasons occurring during the study observation period. | Baseline to End of Treatment (up to Day 47) |
| Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143. |
| 23772042 | Derived | Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141. |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens | Participants with baseline pathogen data documented that had pathogens found to be resistant; n = number of participants with specified pathogen. | Number | percentage of participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | All participants; N = number of participants with nosocomial infections. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
|
|
|
| Primary | Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | All participants; N = number of participants with community-acquired infections. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) |
|
|
|
| Primary | Percentage of Participants With Composite Cure: All Participants | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | All participants. | Posted | Number | percentage of participants | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
|
|
|
| Primary | Percentage of Participants With Composite Cure: Nosocomial Infections | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | All participants; N = number of participants with nosocomial infections. | Posted | Number | percentage of participants | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) |
|
|
|
| Primary | Percentage of Participants With Composite Cure: Community-acquired Infections | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | All participants; N = number participants with community-acquired infections. | Posted | Number | percentage of participants | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) |
|
|
|
| Secondary | Participants With Probable Failure at Follow-up | Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. | All participants. | Posted | Number | participants | Follow-up (up to Day 47) |
|
|
|
| Secondary | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. | All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance. | Posted | Number | percentage of participants | Follow-up (up to Day 47) |
|
|
|
| Secondary | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | Percentage of participants who received each antibiotic administered as combination therapy with tigecycline. | All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil. | Posted | Number | percentage of participants | Baseline to End of Treatment (up to Day 47) |
|
|
|
| Secondary | Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Reasons for change in antibiotic treatment from Tygacil to another antibiotic. | All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible. | Posted | Number | percentage of participants | Baseline to End of Treatment (up to Day 47) |
|
|
|
| Secondary | Reasons for Utilization of Tygacil | All participants; n = number of participants with specified reason for utilization of Tygacil. | Posted | Number | percentage of participants | Baseline to End of Treatment (up to Day 47) |
|
|
|
| Secondary | Overall Mortality: All Participants | Deaths for any reasons occurring during the study observation period. | All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to End of Treatment (up to Day 47) |
|
|
|
| 245 |
| 1,025 |
| 155 |
| 1,025 |
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
|
| Concomitant disease progression | General disorders | MedDRA | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| Brain death | General disorders | MedDRA | Systematic Assessment |
|
| Disease recurrence | General disorders | MedDRA | Systematic Assessment |
|
| Drug resistance | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Candida sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Endocarditis staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fusarium infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pathogen resistance | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic embolus | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection fungal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Bronchopulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Idiopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Ammonia increased | Investigations | MedDRA | Systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Procalcitonin increased | Investigations | MedDRA | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA | Systematic Assessment |
|
| Cardiovascular insufficiency | Vascular disorders | MedDRA | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hypoxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Brain stem ischaemia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Laparotomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Drug effect decreased | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Drug resistance | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema due to cardiac disease | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pathogen resistance | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Stenotrophomonas infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Candida pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Intestinal fistula infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Morganella infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Peritoneal candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia escherichia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Proteus infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Splenic abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Clostridium difficile toxin test positive | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Interleukin level increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nephritis interstitial | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vesical fistula | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lower respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
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.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Proteus mirabilis (n=6) |
|
| Proteus vulgaris (n=2) |
|
| Stenotrophomonas maltophilia (n=4) |
|
| Klebsiella pneumoniae (n=9) |
|
| Enterococcus faecalis (n=10) |
|
| Enterobacter species (spp) (n=11) |
|
| Escherichia coli (n=14) |
|
| Staphylococcus aureus (n=16) |
|
| Enterococcus faecium (n=15) |
|
| Staphylococcus spp (n=5) |
|
| Serratia spp (n=2) |
|
| Citrobacter freundii (n=1) |
|
| Acinetobacter spp. (n=1) |
|
| Title | Measurements |
|---|---|
|
| meropenem (n=49) |
|
| metronidazole (n=48) |
|
| vancomycin (n=27) |
|
| cefepime (n=26) |
|
| pip/tazo (n=18) |
|
| piperacillin (n=14) |
|
| caspofungin (n=13) |
|
| levofloxacin (n=13) |
|
| other antimycotics for system use (n=13) |
|
| imipenem (n=12) |
|
| primaxin (n=12) |
|
| voriconazole (n=11) |
|
| erythromycin (n=10) |
|
| gentamicin (n=10) |
|
| sulbactam (n=10) |
|
| tobramycin (n=10) |
|
| clarithromycin (n=9) |
|
| moxifloxacin (n=9) |
|
| aciclovir (n=7) |
|
| clindamycin (n=7) |
|
| other beta-lactam antibacterials (n=5) |
|
| ampicillin (n=4) |
|
| fosfomycin (n=4) |
|
| linezolid (n=4) |
|
| amikacin (n=3) |
|
| amphotericin B (n=3) |
|
| bactrim (n=3) |
|
| flucloxacillin (n=3) |
|
| rifampicin (n=3) |
|
| unacid (n=3) |
|
| benzylpenicillin (n=2) |
|
| beta-lactam antibacterials, penicillins (n=2) |
|
| ceftriaxone (n=2) |
|
| colistin (n=2) |
|
| doxycycline (n=2) |
|
| ganciclovir (n=2) |
|
| tazobactam (n=2) |
|
| amoxi-clavulanico (n=1) |
|
| antibiotics (n=1) |
|
| azithromycin (n=1) |
|
| cefotaxime (n=1) |
|
| cefuroxime (n=1) |
|
| chloramphenicol (n=1) |
|
| clemizole penicillin (n=1) |
|
| penicillin not otherwise specified (n=1) |
|
| piperacillin with tazobactam (n=1) |
|
| teicoplanin (n=1) |
|
| tienam (n=1) |
|
| Title | Measurements |
|---|---|
|
| Oral treatment continuation (n=14) |
|
| Intolerability (n=5) |
|
|
| Primary (n=114) |
|
| Intolerability to previous antibiotic (n=21) |
|