Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00802854
• Collaborator: (none)
• Enrollment: 244
• Locations: 10
• Actual Duration (Months): 50.6
• Patients Per Site: 24.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Candidemia; Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)

Detailed Description

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".

1. Serious adverse event/adverse drug reaction

2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.

3. Known adverse drug reaction

4. Non-serious adverse drug reaction

5. Other safety and effectiveness information Eraxis was first approved as a new medicine on 30 May 2008. As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug(until 29 May 2014).

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 244 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.
• Actual Study Start Date: Mar 2, 2012
• Actual Primary Completion Date: May 20, 2016
• Actual Study Completion Date: May 20, 2016

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

2. Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

3. Duration of Adverse Events (AEs) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

4. Number of Adverse Events (AEs) by Severity [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

5. Number of Participants With Outcome in Response to Adverse Events (AEs) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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).

6. Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

7. Number of Participants With Laboratory Abnormalities [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

8. Number of Participants With Clinical Response (CR) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

9. Number of Participants With Mycological Response (MR) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

   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.

10. Number of Participants With Overall Response (OR) [From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Prospective Study Population 1.1. Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

• Use in the treatment of invasive candidiasis in adult patients

• Evidence of a personally signed and dated data privacy statement indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

1.2. Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

• Subjects to whom Eraxis IV is prescribed for other diseases than invasive candidiasis in adult patients.

• Subjects less than 18 ages should be excluded in this study since safety and effectiveness in pediatric patients have not been established yet.

• Hypersensitivity to the active substance, or to any of the excipients.

• Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).

1. 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.

• In case where the starting date of Eraxis IV administration is prior to 10 Mar 2015 - Use in the treatment of the following fungal infections: candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis)

• In case where the starting date of Eraxis IV administration is 10 Mar 2015 or after - Use in the treatment of invasive candidiasis in adult patients 2.2. Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

• Subjects to whom Eraxis IV was prescribed for other diseases than candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) (in case where the starting date of Eraxis IV administration is prior to 10 Mar 2015) or invasive candidiasis in adult patients (in case where the starting date of Eraxis IV administration is 10 Mar 2015 or after).

• Subjects less than 18 ages should be excluded in this study since safety and effectiveness in pediatric patients have not been established yet.

• Hypersensitivity to the active substance, or to any of the excipients.

• Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).

• Subjects enrolled in the prospective phase study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Deokjin-gu	Jeollabuk-do	Korea, Republic of	561-712
2	Dong-A University Hospital	Busan		Korea, Republic of	602-715
3	Dong-A University Medical Center (Dong-A University Hospital)	Busen		Korea, Republic of	602-715
4	Keimyung University Dongsan Medical Center (KUDMC)	Daegu		Korea, Republic of	700-712
5	Daegu fatima hospital	Daegu		Korea, Republic of	701-724
6	Daegu Catholic University Medical Center (DCUMC)	Daegu		Korea, Republic of	705-718
7	Ajou University Hospital	Gyeonggi-do		Korea, Republic of	443-721
8	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	120-752
9	Seoul Medical Center	Seoul		Korea, Republic of	131-795
10	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00802854
• Other Study ID Numbers: A8851025
• First Posted: Dec 5, 2008
• Last Update Posted: Nov 21, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Pfizer: anidulafungin; safety; efficacy
• Additional relevant MeSH terms: Peritonitis; Candidemia; Candidiasis; Abdominal Abscess

Study Results

Participant Flow

Arm/Group Title	Eraxis
Arm/Group Description	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.
Period Title: Overall Study
STARTED	244
COMPLETED	244
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Eraxis
Arm/Group Description	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.
Overall Participants	244
Age, Customized (Count of Participants)
Less than (<) 30 years	6 2.5%
30-39 years	19 7.8%
40-49 years	26 10.7%
50-64 years	84 34.4%
Greater than or equal to (>=) 65 years	109 44.7%
Sex: Female, Male (Count of Participants)
Female	107 43.9%
Male	137 56.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of Eraxis.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	244
AEs	141 57.8%
SAEs	102 41.8%

2. Primary Outcome

Title	Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of Eraxis.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	244
Count of Participants [Participants]	8 3.3%

3. Primary Outcome

Title	Duration of Adverse Events (AEs)
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

Subset of safety analysis set which included all participants who had at least 1 AE.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	141
Mean (Standard Deviation) [days]	4.03 (5.81)

4. Primary Outcome

Title	Number of Adverse Events (AEs) by Severity
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of Eraxis.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	244
Mild	33
Moderate	43
Severe	109

5. Primary Outcome

Title	Number of Participants With Outcome in Response to Adverse Events (AEs)
Description	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).
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

Subset of safety analysis set which included all participants who had at least 1 AE.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	141
Yes	106 43.4%
Unknown	7 2.9%
No, resolved	28 11.5%

6. Primary Outcome

Title	Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of Eraxis.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	244
Measure AEs	185
Certain	1.08
Probable/likely	0
Possible	5.95
Unlikely	92.43
Conditional/unclassified	0
Unaccessible/unclassifiable	0.54

7. Primary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	240
Count of Participants [Participants]	35 14.3%

8. Primary Outcome

Title	Number of Participants With Clinical Response (CR)
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	199
Cure	88 36.1%
Improvement	89 36.5%
Failure	19 7.8%
Unevaluable	3 1.2%

9. Primary Outcome

Title	Number of Participants With Mycological Response (MR)
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	199
Eradication	149 61.1%
Presumed eradication	28 11.5%
Persistence	16 6.6%
Presumed persistence	6 2.5%
Unevaluable	0 0%
Superinfection	0 0%

10. Primary Outcome

Title	Number of Participants With Overall Response (OR)
Description	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.
Time Frame	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Eraxis
Arm/Group Description	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.
Measure Participants	199
Effective	173 70.9%
Ineffective	26 10.7%
Unevaluable	0 0%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Arm/Group Title	Eraxis
Arm/Group Description	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.
All Cause Mortality
	Eraxis
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Eraxis
	Affected / at Risk (%)	# Events
Total	102/244 (41.8%)
Blood and lymphatic system disorders
LYMPHOCYTOSIS	1/244 (0.4%)
Cardiac disorders
CARDIAC FAILURE	2/244 (0.8%)
SHOCK	1/244 (0.4%)
CARDIAC ARREST	3/244 (1.2%)
FIBRILLATION VENTRICULAR	1/244 (0.4%)
TACHYCARDIA VENTRICULAR	1/244 (0.4%)
MYOCARDIAL INFARCTION	1/244 (0.4%)
Gastrointestinal disorders
GI HAEMORRHAGE	1/244 (0.4%)
General disorders
MULTIPLE ORGAN FAILURE	7/244 (2.9%)
Hepatobiliary disorders
CHOLANGITIS	1/244 (0.4%)
COMA HEPATIC	1/244 (0.4%)
HEPATIC CIRRHOSIS	1/244 (0.4%)
HEPATIC FAILURE	2/244 (0.8%)
Infections and infestations
INFECTION BACTERIAL	1/244 (0.4%)
CANDIDIASIS	2/244 (0.8%)
PERITONITIS	1/244 (0.4%)
SEPSIS	45/244 (18.4%)
Metabolism and nutrition disorders
ACIDOSIS	2/244 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CARCINOMA	3/244 (1.2%)
GI NEOPLASM MALIGNANT	1/244 (0.4%)
HEPATIC NEOPLASM	2/244 (0.8%)
LEUKAEMIA	1/244 (0.4%)
NEOPLASM MALIGNANT	3/244 (1.2%)
OVARIAN CARCINOMA	1/244 (0.4%)
PANCREAS NEOPLASM MALIGNANT	1/244 (0.4%)
PULMONARY CARCINOMA	1/244 (0.4%)
RECTAL CARCINOMA	2/244 (0.8%)
Nervous system disorders
BRAIN HYPOXIA	1/244 (0.4%)
MENINGOENCEPHALITIS	1/244 (0.4%)
Renal and urinary disorders
RENAL FAILURE ACUTE	3/244 (1.2%)
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	1/244 (0.4%)
PNEUMONIA	8/244 (3.3%)
PULMONARY OEDEMA	1/244 (0.4%)
RESPIRATORY ARREST	1/244 (0.4%)
RESPIRATORY DISTRESS SYNDROME	1/244 (0.4%)
RESPIRATORY INSUFFICIENCY	3/244 (1.2%)
Vascular disorders
ENDOCARDITIS	2/244 (0.8%)
Other (Not Including Serious) Adverse Events
	Eraxis
	Affected / at Risk (%)	# Events
Total	52/244 (21.3%)
Cardiac disorders
HYPERTENSION	4/244 (1.6%)
HYPOTENSION	1/244 (0.4%)
FIBRILLATION ATRIAL	1/244 (0.4%)
Endocrine disorders
ADRENAL INSUFFICIENCY	2/244 (0.8%)
Eye disorders
RETINITIS	2/244 (0.8%)
Gastrointestinal disorders
ABDOMINAL PAIN	1/244 (0.4%)
AMYLASE INCREASED	1/244 (0.4%)
COLITIS	1/244 (0.4%)
COLITIS PSEUDOMEMBRANOUS	1/244 (0.4%)
DIARRHOEA	2/244 (0.8%)
GASTRIC ULCER HAEMORRHAGIC	1/244 (0.4%)
GI HAEMORRHAGE	1/244 (0.4%)
ILEUS	1/244 (0.4%)
MELAENA	3/244 (1.2%)
NAUSEA	1/244 (0.4%)
General disorders
FEVER	6/244 (2.5%)
MEDICINE INEFFECTIVE	2/244 (0.8%)
HERPES NOS	1/244 (0.4%)
INFECTION AGGRAVATED	1/244 (0.4%)
DECUBITUS ULCER	1/244 (0.4%)
MEDICATION ERROR	1/244 (0.4%)
Hepatobiliary disorders
BILIRUBINAEMIA	6/244 (2.5%)
GAMMA-GT INCREASED	1/244 (0.4%)
SGOT INCREASED	2/244 (0.8%)
SGPT INCREASED	3/244 (1.2%)
Infections and infestations
ABSCESS	1/244 (0.4%)
INFECTION BACTERIAL	1/244 (0.4%)
INFECTION FUNGAL	1/244 (0.4%)
SEPSIS	1/244 (0.4%)
URINARY TRACT INFECTION	1/244 (0.4%)
Metabolism and nutrition disorders
LIPASE INCREASED	1/244 (0.4%)
PHOSPHATASE ALKALINE INCREASED	3/244 (1.2%)
Nervous system disorders
CONVULSIONS	3/244 (1.2%)
SPINAL STENOSIS	1/244 (0.4%)
Psychiatric disorders
DELIRIUM	3/244 (1.2%)
DEPRESSION	1/244 (0.4%)
INSOMNIA	2/244 (0.8%)
Renal and urinary disorders
AZOTAEMIA	1/244 (0.4%)
Respiratory, thoracic and mediastinal disorders
PNEUMONIA	1/244 (0.4%)
Skin and subcutaneous tissue disorders
RASH	2/244 (0.8%)
SKIN INFECTION	1/244 (0.4%)
Vascular disorders
THROMBOSIS	1/244 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.