Anidulafungin In Treatment Of Candidemia In Asian Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00537329
• Collaborator: (none)
• Enrollment: 43
• Locations: 13
• Arm: 1
• Duration (Months): 14
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.

Condition or Disease	Intervention/Treatment	Phase
Candidemia	Drug: Anidulafungin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Open This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.	Drug: Anidulafungin; Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Global Response of Success at End of Treatment [End of treatment (EOT) = Day 5 up to Day 42]

   Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.

Secondary Outcome Measures

1. Number of Subjects With Global Response of Success at Endpoints [End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)]

   Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.

2. Number of Subjects With Clinical Response of Success at Endpoints [EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline]

   Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.

3. Number of Subjects With Microbiological Response of Success at Endpoints [EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline]

   Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.

4. Time to Death From Any Cause [Baseline through end of 12 weeks after baseline]

   Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

5. Time to Death Due to Candidemia [Baseline through end of 12 weeks after baseline]

   Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

6. Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment [Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)]

   Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.

7. Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment [Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)]

   Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).

8. Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment [Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)]

   Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).

9. Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT [Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)]

   Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).

10. Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups [EOT (Day 5 up to Day 42)]

    Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects with at least one positive blood test for Candida pathogen from a blood sample taken within 96 hours prior to start of study treatment.

• Subjects with clinical evidence of candida infection within 48 hours prior to enrollment.

• Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20.

Exclusion Criteria:

• Prior exposure to systemic antifungals for more than 48 hours.

• Subjects who had, at any time, previously received anidulafungin.

• Subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples.

• Life expectancy < 72 hours.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ahmedabad	Gujarat	India	380 054
2	Pfizer Investigational Site	Bangalore	Karnataka	India	560034
3	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 022
4	Pfizer Investigational Site	Ludhiana	Punjab	India	141 001
5	Pfizer Investigational Site	Noida	Uttar Pradesh	India	201301
6	Pfizer Investigational Site	Legaspi Village, Makati City		Philippines	1200
7	Pfizer Investigational Site	Pan-Chiao	Taipei	Taiwan	220
8	Pfizer Investigational Site	Taichung		Taiwan	404
9	Pfizer Investigational Site	Tainan		Taiwan	704
10	Pfizer Investigational Site	Taipei		Taiwan	100
11	Pfizer Investigational Site	Pathumwan	Bangkok	Thailand	10330
12	Pfizer Investigational Site	Amphoe Mueang	Chiang Mai	Thailand	50200
13	Pfizer Investigational Site	Amphoe Mueang	Khon Kaen	Thailand	40002

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.

• ClinicalTrials.gov Identifier: NCT00537329
• Other Study ID Numbers: A8851016; PF-03910960
• First Posted: Oct 1, 2007
• Last Update Posted: Mar 9, 2010
• Last Verified: Mar 1, 2010

• Additional relevant MeSH terms: Candidemia; Anidulafungin

Study Results

Participant Flow

Pre-assignment Detail	Approximately 100 eligible subjects from 22 centers were planned to be enrolled. However, due to slow enrollment, 46 subjects were screened and 43 subjects were assigned to treatment.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Period Title: Overall Study
STARTED	43
COMPLETED	17
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Overall Participants	43
Age, Customized (participants) [Number]
Between 18 and 44 years	10 23.3%
Between 45 and 64 years	15 34.9%
≥ 65 years	18 41.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.5 (18.5)
Sex: Female, Male (Count of Participants)
Female	20 46.5%
Male	23 53.5%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Global Response of Success at End of Treatment
Description	Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.
Time Frame	End of treatment (EOT) = Day 5 up to Day 42

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
Number [participants]	31 72.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	86.1
	Confidence Interval	() 95%; 70.5 to 95.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Subjects With Global Response of Success at Endpoints
Description	Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.
Time Frame	End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)

Outcome Measure Data

Analysis Population Description

MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
EOIT	33 76.7%
2 Wks post EOT	24 55.8%
6 Wks post EOT	17 39.5%
12 Wks post baseline	16 37.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	EOIT
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	89.2
	Confidence Interval	() 95%; 74.6 to 97.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	2 Wks post EOT
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	82.8
	Confidence Interval	() 95%; 64.2 to 94.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	6 Wks post EOT
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	89.5
	Confidence Interval	() 95%; 66.9 to 98.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	12 Wks post baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	72.7
	Confidence Interval	() 95%; 49.8 to 89.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Subjects With Clinical Response of Success at Endpoints
Description	Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.
Time Frame	EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline

Outcome Measure Data

Analysis Population Description

MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
EOIT: success (cure/improvement)	34 79.1%
EOIT: cure	27 62.8%
EOIT: improvement	7 16.3%
EOT: success (cure/improvement)	32 74.4%
EOT: cure	27 62.8%
EOT: improvement	5 11.6%
2 Wks post EOT: success (cure/improvement)	26 60.5%
2 Wks post EOT: cure	25 58.1%
2 Wks post EOT: improvement	1 2.3%
6 Wks post EOT: success (cure/improvement)	17 39.5%
6 Wks post EOT: cure	16 37.2%
6 Wks post EOT: improvement	1 2.3%
12 Wks post baseline: success (cure/improvement)	17 39.5%
12 Wks post baseline: cure	17 39.5%
12 Wks post baseline: improvement	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	EOIT: success (cure/improvement)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	97.1
	Confidence Interval	() 95%; 85.1 to 99.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	EOT: success (cure/improvement)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	94.1
	Confidence Interval	() 95%; 80.3 to 99.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	2 Wks post EOT: success (cure/improvement)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	92.9
	Confidence Interval	() 95%; 76.5 to 99.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	6 Wks post EOT: success (cure/improvement)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	94.4
	Confidence Interval	() 95%; 72.7 to 99.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	12 Wks post baseline: success (cure/improvement)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	85.0
	Confidence Interval	() 95%; 62.1 to 96.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Subjects With Microbiological Response of Success at Endpoints
Description	Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.
Time Frame	EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline

Outcome Measure Data

Analysis Population Description

MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
EOIT: success (erad/presumed erad)	36 83.7%
EOIT: erad	31 72.1%
EOIT: presumed erad	5 11.6%
EOT: success (erad/presumed erad)	34 79.1%
EOT: erad	31 72.1%
EOT: presumed erad	3 7%
2 Wks post EOT: success (erad/presumed erad)	25 58.1%
2 Wks post EOT: erad	22 51.2%
2 Wks post EOT: presumed erad	3 7%
6 Wks post EOT: success (erad/presumed erad)	17 39.5%
6 Wks post EOT: erad	14 32.6%
6 Wks post EOT: presumed erad	3 7%
12 Wks post baseline: success (erad/presumed erad)	16 37.2%
12 Wks post baseline: erad	14 32.6%
12 Wks post baseline: presumed erad	2 4.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	EOIT: success (erad/presumed erad)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	97.3
	Confidence Interval	() 95%; 85.8 to 99.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	EOT: success (erad/presumed erad)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	97.1
	Confidence Interval	() 95%; 85.1 to 99.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	2 Wks post EOT: success (erad/presumed erad)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	86.2
	Confidence Interval	() 95%; 68.3 to 96.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	6 Wks post EOT: success (erad/presumed erad)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	94.4
	Confidence Interval	() 95%; 72.7 to 99.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	12 Wks post baseline: success (erad/presumed erad)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	84.2
	Confidence Interval	() 95%; 60.4 to 96.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Time to Death From Any Cause
Description	Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Time Frame	Baseline through end of 12 weeks after baseline

Outcome Measure Data

Analysis Population Description

MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; < 50% of subjects died out of the analyzable population.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	0

6. Secondary Outcome

Title	Time to Death Due to Candidemia
Description	Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
Time Frame	Baseline through end of 12 weeks after baseline

Outcome Measure Data

Analysis Population Description

MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	0

7. Secondary Outcome

Title	Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Description	Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.
Time Frame	Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. "All" category includes all subjects with success or failure at EOT.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
Success at EOT: baseline β-D-glucan (n=30)	1095.8 (968.52)
Failure at EOT: baseline β-D-glucan (n=10)	1447.9 (2178.27)
All at EOT: baseline β-D-glucan (n=40)	1183.9 (1347.71)
Success at EOT: Day 3 β-D-glucan (n=32)	1132.0 (1249.22)
Failure at EOT: Day 3 β-D-glucan (n=4)	2753.3 (3991.50)
All at EOT: Day 3 β-D-glucan (n=36)	1312.1 (1736.33)
Success at EOT: Day 5 β-D-glucan (n=29)	1140.5 (1149.22)
Failure at EOT: Day 5 β-D-glucan (n=6)	2443.8 (3987.38)
All at EOT: Day 5 β-D-glucan (n=35)	1363.9 (1916.80)
Success at EOT: Day 7 β-D-glucan (n=24)	1190.8 (1011.93)
Failure at EOT: Day 7 β-D-glucan (n=4)	3140.8 (4436.99)
All at EOT: Day 7 β-D-glucan (n=28)	1469.4 (1882.17)
Success at EOT: EOT β-D-glucan (n=28)	1018.9 (783.76)
Failure at EOT: EOT β-D-glucan (n=3)	2917.7 (4737.50)
All at EOT: EOT β-D-glucan (n=31)	1202.7 (1541.02)

8. Secondary Outcome

Title	Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
Description	Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).
Time Frame	Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. "All" category includes all subjects with success or failure at EOT.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
Success at EOT: Day 3 β-D-glucan (n=30)	-0.4 (50.56)
Failure at EOT: Day 3 β-D-glucan (n=4)	-11.0 (51.50)
All at EOT: Day 3 β-D-glucan (n=34)	-1.7 (49.99)
Success at EOT: Day 5 β-D-glucan (n=27)	-1.0 (52.14)
Failure at EOT: Day 5 β-D-glucan (n=6)	1.3 (54.36)
All at EOT: Day 5 β-D-glucan (n=33)	-0.6 (51.68)
Success at EOT: Day 7 β-D-glucan (n=23)	4.3 (55.37)
Failure at EOT: Day 7 β-D-glucan (n=4)	4.5 (24.14)
All at EOT: Day 7 β-D-glucan (n=27)	4.3 (51.59)
Success at EOT: EOT β-D-glucan (n=27)	7.0 (69.64)
Failure at EOT: EOT β-D-glucan (n=3)	14.0 (18.41)
All at EOT: EOT β-D-glucan (n=30)	7.7 (66.15)

9. Secondary Outcome

Title	Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
Description	Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).
Time Frame	Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. "All" category includes all subjects with success or failure at EOT.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
Success at EOT: baseline β-D-glucan (n=32)	1219.7 (1491.27)
Failure at EOT: baseline β-D-glucan (n=8)	1040.4 (491.35)
All at EOT: baseline β-D-glucan (n=40)	1183.9 (1347.71)
Success at EOT: Day 3 β-D-glucan (n=32)	1349.0 (1826.61)
Failure at EOT: Day 3 β-D-glucan (n=4)	1017.4 (752.22)
All at EOT: Day 3 β-D-glucan (n=36)	1312.1 (1736.33)
Success at EOT: Day 5 β-D-glucan (n=29)	1444.3 (2087.84)
Failure at EOT: Day 5 β-D-glucan (n=6)	975.3 (595.29)
All at EOT: Day 5 β-D-glucan (n=35)	1363.9 (1916.80)
Success at EOT: Day 7 β-D-glucan (n=24)	1527.2 (2023.77)
Failure at EOT: Day 7 β-D-glucan (n=4)	1122.3 (544.01)
All at EOT: Day 7 β-D-glucan (n=28)	1469.4 (1882.17)
Success at EOT: EOT β-D-glucan (n=31)	1202.7 (1541.02)
All at EOT: EOT β-D-glucan (n=31)	1202.7 (1541.02)

10. Secondary Outcome

Title	Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
Description	Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).
Time Frame	Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. "All" category includes all subjects with success or failure at EOT.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
Success at EOT: Day 3 β-D-glucan (n=30)	0.0 (50.64)
Failure at EOT: Day 3 β-D-glucan (n=4)	-14.3 (49.60)
All at EOT: Day 3 β-D-glucan (n=34)	-1.7 (49.99)
Success at EOT: Day 5 β-D-glucan (n=27)	0.4 (52.75)
Failure at EOT: Day 5 β-D-glucan (n=6)	-5.2 (50.95)
All at EOT: Day 5 β-D-glucan (n=33)	-0.6 (51.68)
Success at EOT: Day 7 β-D-glucan (n=23)	5.6 (55.63)
Failure at EOT: Day 7 β-D-glucan (n=4)	-3.0 (16.97)
All at EOT: Day 7 β-D-glucan (n=27)	4.3 (51.59)
Success at EOT: EOT β-D-glucan (n=30)	7.7 (66.15)
All at EOT: Day 7 β-D-glucan (n=30)	7.7 (66.15)

11. Secondary Outcome

Title	Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
Description	Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.
Time Frame	EOT (Day 5 up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT. May have >1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation.

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
Measure Participants	42
Neutropenic status: ANC ≤ 500/cmm (n=2)	1 2.3%
Neutropenic status: ANC >500/cmm (n=37)	28 65.1%
Baseline pathogen: Candida albicans (n=14)	10 23.3%
Baseline pathogen: Candida glabrata (n=6)	4 9.3%
Baseline pathogen: Candida parapsilosis (n=4)	4 9.3%
Baseline pathogen: Candida rugosa (n=1)	1 2.3%
Baseline pathogen: Candida tropicalis (n=18)	13 30.2%
Previous surgery: Any surgery (n=13)	11 25.6%
Previous surgery: Abdominal surgery (n=8)	7 16.3%
Elderly: Age ≥ 65 years (n=17)	10 23.3%
Renal insufficiency (CCC < 30 mL/min) (n=11)	6 14%
Use of Central venous catheter = Yes (n=21)	17 39.5%
Receiving chemotherapy = Yes (n=7)	5 11.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Neutropenic status: ANC ≤ 500/cmm
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	50.0
	Confidence Interval	() 95%; 1.3 to 98.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Neutropenic status: ANC > 500/cmm
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	75.7
	Confidence Interval	() 95%; 58.8 to 88.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Baseline pathogen: Candida albicans
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	71.4
	Confidence Interval	() 95%; 41.9 to 91.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Baseline pathogen: Candida glabrata
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	66.7
	Confidence Interval	() 95%; 22.3 to 95.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Baseline pathogen: Candida parapsilosis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	100.0
	Confidence Interval	() 95%; 39.8 to 100.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Baseline pathogen: Candida rugosa
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	100.0
	Confidence Interval	() 95%; 2.5 to 100.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Baseline pathogen: Candida tropicalis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	72.2
	Confidence Interval	() 95%; 46.5 to 90.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Previous surgery: Any surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	84.6
	Confidence Interval	() 95%; 54.6 to 98.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Previous surgery: Abdominal surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	87.5
	Confidence Interval	() 95%; 47.3 to 99.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Elderly: Age ≥ 65 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	58.8
	Confidence Interval	() 95%; 32.9 to 81.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Renal insufficiency (CCC < 30 mL/min)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	54.5
	Confidence Interval	() 95%; 23.4 to 83.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Use of Central venous catheter = Yes
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	81.0
	Confidence Interval	() 95%; 58.1 to 94.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Receiving chemotherapy = Yes
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	2-sided exact Clopper-Pearson (percent)
	Estimated Value	71.4
	Confidence Interval	() 95%; 29.0 to 96.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Anidulafungin
Arm/Group Description	Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
All Cause Mortality
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	16/43 (37.2%)
Cardiac disorders
Cardiac failure congestive	1/43 (2.3%)
Cardio-respiratory arrest	1/43 (2.3%)
Myocardial infarction	1/43 (2.3%)
Gastrointestinal disorders
Upper gastrointestinal haemorrhage	1/43 (2.3%)
General disorders
Chills	1/43 (2.3%)
Pyrexia	1/43 (2.3%)
Infections and infestations
Bacteraemia	1/43 (2.3%)
Pneumonia	1/43 (2.3%)
Septic shock	2/43 (4.7%)
Systemic candida	1/43 (2.3%)
Metabolism and nutrition disorders
Hypernatraemia	1/43 (2.3%)
Hypoglycaemia	1/43 (2.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer	1/43 (2.3%)
Gastric cancer	1/43 (2.3%)
Hepatic neoplasm malignant	1/43 (2.3%)
Lung neoplasm malignant	1/43 (2.3%)
Pancreatic carcinoma	1/43 (2.3%)
Nervous system disorders
Cerebrovascular accident	1/43 (2.3%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/43 (2.3%)
Respiratory failure	1/43 (2.3%)
Vascular disorders
Hypotension	1/43 (2.3%)
Other (Not Including Serious) Adverse Events
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	30/43 (69.8%)
Blood and lymphatic system disorders
Leukopenia	2/43 (4.7%)
Thrombocytopenia	1/43 (2.3%)
Cardiac disorders
Acute coronary syndrome	1/43 (2.3%)
Cardiac failure congestive	1/43 (2.3%)
Tachycardia	2/43 (4.7%)
Eye disorders
Asthenopia	1/43 (2.3%)
Conjunctivitis	1/43 (2.3%)
Gastrointestinal disorders
Abdominal pain	2/43 (4.7%)
Ascites	1/43 (2.3%)
Constipation	3/43 (7%)
Diarrhoea	8/43 (18.6%)
Flatulence	1/43 (2.3%)
Ileus	1/43 (2.3%)
Nausea	2/43 (4.7%)
Peritonitis	1/43 (2.3%)
Upper gastrointestinal haemorrhage	2/43 (4.7%)
Vomiting	3/43 (7%)
General disorders
Chest discomfort	1/43 (2.3%)
Chest pain	1/43 (2.3%)
Oedema peripheral	2/43 (4.7%)
Pain	2/43 (4.7%)
Pitting oedema	2/43 (4.7%)
Pyrexia	1/43 (2.3%)
Thirst	1/43 (2.3%)
Hepatobiliary disorders
Jaundice	1/43 (2.3%)
Immune system disorders
Drug hypersensitivity	1/43 (2.3%)
Infections and infestations
Abscess limb	1/43 (2.3%)
Acarodermatitis	1/43 (2.3%)
Bacteraemia	2/43 (4.7%)
Bacterial sepsis	1/43 (2.3%)
Cellulitis	1/43 (2.3%)
Nasopharyngitis	1/43 (2.3%)
Nosocomial infection	1/43 (2.3%)
Oral candidiasis	3/43 (7%)
Pneumonia	1/43 (2.3%)
Sepsis	2/43 (4.7%)
Systemic candida	1/43 (2.3%)
Urosepsis	1/43 (2.3%)
Investigations
ECG signs of myocardial ischaemia	1/43 (2.3%)
Transaminases increased	1/43 (2.3%)
Metabolism and nutrition disorders
Cachexia	1/43 (2.3%)
Dehydration	1/43 (2.3%)
Fluid overload	2/43 (4.7%)
Hyperammonaemia	1/43 (2.3%)
Hyperglycaemia	2/43 (4.7%)
Hyperkalaemia	2/43 (4.7%)
Hypernatraemia	3/43 (7%)
Hypocalcaemia	1/43 (2.3%)
Hypoglycaemia	1/43 (2.3%)
Hypokalaemia	5/43 (11.6%)
Hypophosphataemia	1/43 (2.3%)
Metabolic acidosis	1/43 (2.3%)
Musculoskeletal and connective tissue disorders
Back pain	1/43 (2.3%)
Flank pain	1/43 (2.3%)
Myalgia	1/43 (2.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	1/43 (2.3%)
Nervous system disorders
Convulsion	1/43 (2.3%)
Depressed level of consciousness	1/43 (2.3%)
Hepatic encephalopathy	1/43 (2.3%)
Somnolence	1/43 (2.3%)
Psychiatric disorders
Anxiety	2/43 (4.7%)
Confusional state	1/43 (2.3%)
Delirium	1/43 (2.3%)
Depression	1/43 (2.3%)
Insomnia	4/43 (9.3%)
Renal and urinary disorders
Azotaemia	1/43 (2.3%)
Haematuria	1/43 (2.3%)
Hydronephrosis	1/43 (2.3%)
Renal failure acute	1/43 (2.3%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm	2/43 (4.7%)
Choking	1/43 (2.3%)
Cough	2/43 (4.7%)
Dyspnoea	1/43 (2.3%)
Hypercapnia	1/43 (2.3%)
Oropharyngeal pain	1/43 (2.3%)
Pulmonary embolism	1/43 (2.3%)
Respiratory tract haemorrhage	1/43 (2.3%)
Wheezing	1/43 (2.3%)
Skin and subcutaneous tissue disorders
Drug eruption	1/43 (2.3%)
Dry skin	1/43 (2.3%)
Rash	3/43 (7%)
Rash pruritic	1/43 (2.3%)
Vascular disorders
Deep vein thrombosis	1/43 (2.3%)
Hypertension	1/43 (2.3%)
Hypotension	3/43 (7%)
Thrombophlebitis	1/43 (2.3%)

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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.