Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tigecycline (Tygacil) | Subjects who are treated with tigecycline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigecycline (Tygacil) | Drug | Tigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reaction (ADR) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician. | Up until 14 days from the start date and 28 days from the end of the observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate | Clinical response rate, which was defined as the percentage of participants who achieved clinical response as "effective" over the total number of assessable effectiveness analysis population("effective" plus "ineffective",) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as "effective," "ineffective," or "indeterminate" by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tygacil (Tigecycline) | Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 116 participants were registered in this study. There was no participant excluded from the baseline analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tygacil (Tigecycline) | Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Adverse Drug Reaction (ADR) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician. | The safety analysis set comprised of participants who had received Tygacil at least once. | Posted | Number | Participants | Up until 14 days from the start date and 28 days from the end of the observation period |
|
Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tygacil (Tigecycline) | Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2016 | Jun 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2017 | Jun 12, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Within 14 days from the start date |
| Clinical Response Rate of Cure | The cure rate, which was defined as the percentage of participants who were assessed as "cure" over the total number of assessable effectiveness analysis population ("cure" plus "failure"), was presented along with two-sided 95% CI. Clinical response of cure was assessed as "cure," "failure," or "indeterminate" by the physician within 28 days post-treatment. | Within 28 days post-treatment |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Clinical Response Rate | Clinical response rate, which was defined as the percentage of participants who achieved clinical response as "effective" over the total number of assessable effectiveness analysis population("effective" plus "ineffective",) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as "effective," "ineffective," or "indeterminate" by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings. | The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end date of the observation period at least once. Participants evaluated as "indeterminate (n=28)" were excluded from the calculation. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Within 14 days from the start date |
|
|
|
| Secondary | Clinical Response Rate of Cure | The cure rate, which was defined as the percentage of participants who were assessed as "cure" over the total number of assessable effectiveness analysis population ("cure" plus "failure"), was presented along with two-sided 95% CI. Clinical response of cure was assessed as "cure," "failure," or "indeterminate" by the physician within 28 days post-treatment. | The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the Test-of-Cure visit at least once. Participants evaluated as "indeterminate (n=38) " were excluded from the calculation. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Within 28 days post-treatment |
|
|
|
| 42 |
| 116 |
| 49 |
| 116 |
| 54 |
| 116 |
| Venous thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Stenotrophomonas infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pathogen resistance | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Oral viral infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Mucormycosis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Meningoencephalitis herpetic | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Encephalitis viral | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute graft versus host disease | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Mucous membrane disorder | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pancreatic enzymes increased | Investigations | MedDRA 20.0 | Non-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 |