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The objective of this study is to collect the safety and efficacy data of Eraxis IV (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.
The objective of this study is to determine any problems or questions associated with Eraxis after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".
However, minimal required number of subjects was not met during the original reexamination period (30 May 2008 ~ 29 May 2014). Therefore, according to an order from MFDS on 02 Mar 2015, Eraxis PMS was requested to collect the rest of required subjects by 02 September 2016 in prospective and retrospective approach.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Duration of Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. |
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Prospective Study Population 1.1. Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1.2. Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
Retrospective Study Population 2.1. Inclusion Criteria
Subjects must meet one of the following inclusion criteria to be eligible for enrollment into the study:
Since all subjects enrolled should meet the usual prescribing criteria as per the local product document of Eraxis IV at the time of starting Eraxis IV administration, the inclusion criteria is divided as followings on the basis of 10 Mar 2015 when the approved indication was updated.
Subjects presenting with any of the following will not be included in the study:
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200 subjects will be studied according to the review result by the MFDS for the request for the adjustment of number of subjects.
To achieve the target sample size, the study is being conducted in prospective study design and retrospective study design.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Deokjin-gu | Jeollabuk-do | 561-712 | South Korea | ||
| Dong-A University Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eraxis | Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all participants who received at least 1 dose of Eraxis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eraxis | Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | Safety analysis set included all participants who received at least 1 dose of Eraxis. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
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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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious 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 | Eraxis | Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MULTIPLE ORGAN FAILURE | General disorders | WHO-ART 092 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEVER | General disorders | WHO-ART 092 | Non-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 |
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Participants With Outcome in Response to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved). | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) | AE=any untoward medical occurrence attributed to study drug in participant who received study drug. Treatment-emergent AE=AE between first dose of study drug up to 28 days after last dose that were absent before treatment/worsened relative to pretreatment state. Relatedness of AE to treatment assessed by physician as:Certain=clinically reasonable reaction on cessation of treatment;Probable/likely=followed reasonable time sequence from administration of treatment which was not explained by other drug/chemical substance/accompanying disease;Possible=followed reasonable time sequence from administration of treatment;Unlikely=not likely to have reasonable causal relationship with treatment, seems temporary;Conditional/unclassified=needed more data to make appropriate assessment/its additional data were being reviewed;Unaccessible/unclassifiable=lack of sufficient information hampered accurate causality assessment. % of AEs=(Number of AEs for specified categories/total number of AEs)*100. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Participants With Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Participants With Clinical Response (CR) | CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Participants With Mycological Response (MR) | In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Number of Participants With Overall Response (OR) | OR: final effectiveness evaluation analyzed using following criteria (based on physician's evaluation of CR & MR): a)Effective:clinical success (cure/improvement) & microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR & MR & neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist & CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection. | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
| Busan |
| 602-715 |
| South Korea |
| Dong-A University Medical Center (Dong-A University Hospital) | Busen | 602-715 | South Korea |
| Keimyung University Dongsan Medical Center (KUDMC) | Daegu | 700-712 | South Korea |
| Daegu fatima hospital | Daegu | 701-724 | South Korea |
| Daegu Catholic University Medical Center (DCUMC) | Daegu | 705-718 | South Korea |
| Ajou University Hospital | Gyeonggi-do | 443-721 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Seoul Medical Center | Seoul | 131-795 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response. |
|
|
| Primary | Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety analysis set included all participants who received at least 1 dose of Eraxis. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Duration of Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE. | Subset of safety analysis set which included all participants who had at least 1 AE. | Posted | Mean | Standard Deviation | days | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Number of Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. | Safety analysis set included all participants who received at least 1 dose of Eraxis. | Posted | Number | events | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Number of Participants With Outcome in Response to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved). | Subset of safety analysis set which included all participants who had at least 1 AE. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) | AE=any untoward medical occurrence attributed to study drug in participant who received study drug. Treatment-emergent AE=AE between first dose of study drug up to 28 days after last dose that were absent before treatment/worsened relative to pretreatment state. Relatedness of AE to treatment assessed by physician as:Certain=clinically reasonable reaction on cessation of treatment;Probable/likely=followed reasonable time sequence from administration of treatment which was not explained by other drug/chemical substance/accompanying disease;Possible=followed reasonable time sequence from administration of treatment;Unlikely=not likely to have reasonable causal relationship with treatment, seems temporary;Conditional/unclassified=needed more data to make appropriate assessment/its additional data were being reviewed;Unaccessible/unclassifiable=lack of sufficient information hampered accurate causality assessment. % of AEs=(Number of AEs for specified categories/total number of AEs)*100. | Safety analysis set included all participants who received at least 1 dose of Eraxis. | Posted | Number | percentage of AEs | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis | AEs | AEs |
|
|
|
| Primary | Number of Participants With Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator. | Safety analysis set included all participants who received at least 1 dose of Eraxis. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Number of Participants With Clinical Response (CR) | CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up. | Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Number of Participants With Mycological Response (MR) | In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site. | Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| Primary | Number of Participants With Overall Response (OR) | OR: final effectiveness evaluation analyzed using following criteria (based on physician's evaluation of CR & MR): a)Effective:clinical success (cure/improvement) & microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR & MR & neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist & CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection. | Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once. | Posted | Count of Participants | Participants | From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis |
|
|
|
| 102 |
| 244 |
| 52 |
| 244 |
| CARDIAC FAILURE | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SHOCK | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| BRAIN HYPOXIA | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| MENINGOENCEPHALITIS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GI HAEMORRHAGE | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| FIBRILLATION VENTRICULAR | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| TACHYCARDIA VENTRICULAR | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| COMA HEPATIC | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ACIDOSIS | Metabolism and nutrition disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ENDOCARDITIS | Vascular disorders | WHO-ART 092 | Non-systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GASTRIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| GI NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| HEPATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| OVARIAN CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| PANCREAS NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| PULMONARY CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| RECTAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| INFECTION BACTERIAL | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| CANDIDIASIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| PERITONITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RESPIRATORY INSUFFICIENCY | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| LYMPHOCYTOSIS | Blood and lymphatic system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| MEDICINE INEFFECTIVE | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| HYPERTENSION | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| HYPOTENSION | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| CONVULSIONS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SPINAL STENOSIS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ADRENAL INSUFFICIENCY | Endocrine disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| AMYLASE INCREASED | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| COLITIS PSEUDOMEMBRANOUS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GASTRIC ULCER HAEMORRHAGIC | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GI HAEMORRHAGE | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| FIBRILLATION ATRIAL | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
|
| BILIRUBINAEMIA | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GAMMA-GT INCREASED | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SGOT INCREASED | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SGPT INCREASED | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| LIPASE INCREASED | Metabolism and nutrition disorders | WHO-ART 092 | Non-systematic Assessment |
|
| PHOSPHATASE ALKALINE INCREASED | Metabolism and nutrition disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ABSCESS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| HERPES NOS | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| INFECTION AGGRAVATED | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| INFECTION BACTERIAL | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| INFECTION FUNGAL | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DECUBITUS ULCER | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| MEDICATION ERROR | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SKIN INFECTION | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| AZOTAEMIA | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
|
| THROMBOSIS | Vascular disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RETINITIS | Eye disorders | WHO-ART 092 | 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.
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059413 | Intraabdominal Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Unlikely |
|
| Conditional/unclassified |
|
| Unaccessible/unclassifiable |
|
| Title | Measurements |
|---|
|
| Unevaluable |
|
| Title | Measurements |
|---|---|
|
| Presumed persistence |
|
| Unevaluable |
|
| Superinfection |
|
| Title | Measurements |
|---|---|
|