ICE: Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00689338
• Collaborator: (none)
• Enrollment: 216
• Locations: 61
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Condition or Disease	Intervention/Treatment	Phase
Invasive Candidiasis	Drug: Anidulafungin; Drug: Fluconazole; Drug: Voriconazole	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Option to treat with oral azole therapy following treatment with anidulafungin	Drug: Anidulafungin; Anidulafungin Intravenous Administration; Drug: Fluconazole; Oral Administration of Fluconazole; Drug: Voriconazole; Oral Administration of Voriconazole

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Global Treatment Response Success at End of Treatment [End of Treatment (Day 14 to Day 56)]

   Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

Secondary Outcome Measures

1. Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) [EOIVT (Day 10 up to Day 42)]

   Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

2. Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment [2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)]

   Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

3. Percentage of Participants With Global Response Success 6 Weeks After End of Treatment [6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)]

   Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

4. Time to First Negative Blood Culture [Day 1 up to Day 42]

   Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.

5. Day 90 Survival [Day 90]

   Percentage of participants known or assumed to be alive on Day 90.

6. Time to Successful Intensive Care Unit (ICU) Discharge [Day 1 up to Day 56]

   Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

• Post-abdominal surgery.

• Elderly > 65 years old.

• Renal insufficiency / failure / hemodialysis.

• Solid tumor.

• Solid-organ (liver, kidney, lung, heart) transplant recipients.

• Hepatic insufficiency.

• Neutropenic including hematology oncology patients.

Exclusion Criteria:

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Wien		Austria	A-1090
2	Pfizer Investigational Site	Brussels		Belgium	B-1070
3	Pfizer Investigational Site	Brussel		Belgium	1090
4	Pfizer Investigational Site	Gent		Belgium	9000
5	Pfizer Investigational Site	Leuven		Belgium	3000
6	Pfizer Investigational Site	Liege		Belgium	B-4000
7	Pfizer Investigational Site	Yvoir		Belgium	5530
8	Pfizer Investigational Site	Hamilton	Ontario	Canada	L8N 3Z5
9	Pfizer Investigational Site	Hamilton	Ontario	Canada	L8N 4A6
10	Pfizer Investigational Site	Quebec		Canada	G1R 2J6
11	Pfizer Investigational Site	Brno		Czech Republic	656 91
12	Pfizer Investigational Site	Ostrava		Czech Republic	708 52
13	Pfizer Investigational Site	Praha 10		Czech Republic	100 34
14	Pfizer Investigational Site	Koebenhavn OE		Denmark	2100
15	Pfizer Investigational Site	Odense C		Denmark	5000
16	Pfizer Investigational Site	Amiens		France	80054
17	Pfizer Investigational Site	Bordeaux		France	33076
18	Pfizer Investigational Site	Clichy		France	92110
19	Pfizer Investigational Site	Lyon		France	69433
20	Pfizer Investigational Site	Marseille		France	13385
21	Pfizer Investigational Site	Montpellier		France	34295
22	Pfizer Investigational Site	Paris Cedex 18		France	75877
23	Pfizer Investigational Site	Villejuif Cedex		France	94804
24	Pfizer Investigational Site	Berlin		Germany	10117
25	Pfizer Investigational Site	Freiburg		Germany	79106
26	Pfizer Investigational Site	Wuppertal		Germany	42283
27	Pfizer Investigational Site	Kifisia	Athens	Greece	14561
28	Pfizer Investigational Site	Haidari	Attiki	Greece	12462
29	Pfizer Investigational Site	Budapest		Hungary	1106
30	Pfizer Investigational Site	Budapest		Hungary	1125
31	Pfizer Investigational Site	Pisa		Italy	56124
32	Pfizer Investigational Site	Roma		Italy	00161
33	Pfizer Investigational Site	Roma		Italy	00168
34	Pfizer Investigational Site	Torino		Italy	10143
35	Pfizer Investigational Site	Udine		Italy	33100
36	Pfizer Investigational Site	Ede		Netherlands	6716 RP
37	Pfizer Investigational Site	Rotterdam		Netherlands	3083 AN
38	Pfizer Investigational Site	Krakow		Poland	31-501
39	Pfizer Investigational Site	Lodz		Poland	90-153
40	Pfizer Investigational Site	Coimbra		Portugal	3040-853
41	Pfizer Investigational Site	Lisboa		Portugal	1349-019
42	Pfizer Investigational Site	Porto		Portugal	4200-072
43	Pfizer Investigational Site	Porto		Portugal	4200-319
44	Pfizer Investigational Site	Bucuresti		Romania	022328
45	Pfizer Investigational Site	Iasi		Romania	700111
46	Pfizer Investigational Site	Moscow		Russian Federation	115478
47	Pfizer Investigational Site	Moscow		Russian Federation	121552
48	Pfizer Investigational Site	Moscow		Russian Federation	125167
49	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	191015
50	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	194291
51	Pfizer Investigational Site	Bratislava		Slovakia	033 10
52	Pfizer Investigational Site	Bratislava		Slovakia	851 07
53	Pfizer Investigational Site	Kosice		Slovakia	041 66
54	Pfizer Investigational Site	Gorukle	Bursa	Turkey	16045
55	Pfizer Investigational Site	Ankara		Turkey	06100
56	Pfizer Investigational Site	Trabzon		Turkey	61080
57	Pfizer Investigational Site	Dnipropetrovsk		Ukraine	49600
58	Pfizer Investigational Site	Donetsk		Ukraine	84003
59	Pfizer Investigational Site	Leeds	West Yorkshire	United Kingdom	LS1 3EX
60	Pfizer Investigational Site	Liverpool		United Kingdom	L7 8XP
61	Pfizer Investigational Site	London		United Kingdom	SE5 9RS

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: NCT00689338
• Other Study ID Numbers: A8851019
• First Posted: Jun 3, 2008
• Last Update Posted: May 30, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: Candida; Candidemia; Systemic Candidiasis; ICU; Intensive Care Unit; Critical Care Unit; Anidulafungin; Ecalta; Eraxis; Fluconazole; Voriconazole
• Additional relevant MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive; Fluconazole; Voriconazole; Anidulafungin

Study Results

Participant Flow

Recruitment Details	Adult specific participants were recruited from intensive care unit (ICU) populations.
Pre-assignment Detail	Two-hundred twenty one (221) participants were screened; 5 participants were screen failures who did not receive study medication.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Period Title: Overall Study
STARTED	216
COMPLETED	73
NOT COMPLETED	143

Baseline Characteristics

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Overall Participants	216
Age, Customized (participants) [Number]
<18 years	0 0%
18 to 44 years	27 12.5%
45 to 64 years	89 41.2%
≥ 65 years	100 46.3%
Sex: Female, Male (Count of Participants)
Female	85 39.4%
Male	131 60.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Global Treatment Response Success at End of Treatment
Description	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Time Frame	End of Treatment (Day 14 to Day 56)

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	154
Number (95% Confidence Interval) [percentage of participants]	69.5 32.2%

2. Secondary Outcome

Title	Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)
Description	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Time Frame	EOIVT (Day 10 up to Day 42)

Outcome Measure Data

Analysis Population Description

MITT; N excludes participants with missing or unknown global responses.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	157
Number (95% Confidence Interval) [percentage of participants]	70.7 32.7%

3. Secondary Outcome

Title	Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment
Description	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Time Frame	2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)

Outcome Measure Data

Analysis Population Description

MITT; N excludes participants with missing or unknown global responses.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	128
Number (95% Confidence Interval) [percentage of participants]	60.2 27.9%

4. Secondary Outcome

Title	Percentage of Participants With Global Response Success 6 Weeks After End of Treatment
Description	Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Time Frame	6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)

Outcome Measure Data

Analysis Population Description

MITT; N excludes participants with missing or unknown global responses.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	109
Number (95% Confidence Interval) [percentage of participants]	50.5 23.4%

5. Secondary Outcome

Title	Time to First Negative Blood Culture
Description	Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.
Time Frame	Day 1 up to Day 42

Outcome Measure Data

Analysis Population Description

MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	87
Mean (95% Confidence Interval) [days]	3.7

6. Secondary Outcome

Title	Day 90 Survival
Description	Percentage of participants known or assumed to be alive on Day 90.
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

MITT

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	170
Number (95% Confidence Interval) [percentage of participants]	54.1 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anidulafungin
	Comments	Kaplan-Meier estimate of survival at Day 90 (survivor function).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	estimate of survival
	Estimated Value	53.8
	Confidence Interval	(2-Sided) 95%; 45.9 to 60.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Time to Successful Intensive Care Unit (ICU) Discharge
Description	Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.
Time Frame	Day 1 up to Day 56

Outcome Measure Data

Analysis Population Description

MITT. N = participants who had a successful ICU discharge.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
Measure Participants	49
Mean (95% Confidence Interval) [days]	16.2

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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
All Cause Mortality
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	107/216 (49.5%)
Blood and lymphatic system disorders
Anaemia	1/216 (0.5%)
Thrombocytopenia	1/216 (0.5%)
Cardiac disorders
Atrial fibrillation	1/216 (0.5%)
Cardiac arrest	10/216 (4.6%)
Cardiac failure	5/216 (2.3%)
Cardiac failure acute	1/216 (0.5%)
Cardio-respiratory arrest	5/216 (2.3%)
Cardiopulmonary failure	1/216 (0.5%)
Cardiovascular disorder	1/216 (0.5%)
Myocardial infarction	1/216 (0.5%)
Tachycardia	1/216 (0.5%)
Gastrointestinal disorders
Diarrhoea	2/216 (0.9%)
Gastrointestinal haemorrhage	2/216 (0.9%)
Gastrointestinal obstruction	1/216 (0.5%)
Haematemesis	1/216 (0.5%)
Ileus paralytic	1/216 (0.5%)
Intestinal ischaemia	2/216 (0.9%)
Intestinal obstruction	1/216 (0.5%)
Pancreatic fistula	1/216 (0.5%)
Pancreatic necrosis	1/216 (0.5%)
Peritonitis	2/216 (0.9%)
Rectal haemorrhage	1/216 (0.5%)
Stress ulcer	1/216 (0.5%)
Upper gastrointestinal haemorrhage	1/216 (0.5%)
General disorders
Chills	1/216 (0.5%)
Death	1/216 (0.5%)
Disease progression	1/216 (0.5%)
General physical health deterioration	1/216 (0.5%)
Infusion related reaction	1/216 (0.5%)
Multi-organ disorder	2/216 (0.9%)
Multi-organ failure	12/216 (5.6%)
Sudden death	1/216 (0.5%)
Hepatobiliary disorders
Haemobilia	1/216 (0.5%)
Hepatic failure	1/216 (0.5%)
Hepatic haemorrhage	1/216 (0.5%)
Pneumobilia	1/216 (0.5%)
Infections and infestations
Abdominal abscess	1/216 (0.5%)
Cellulitis	1/216 (0.5%)
Fungaemia	1/216 (0.5%)
Lung infection pseudomonal	1/216 (0.5%)
Nosocomial infection	1/216 (0.5%)
Pancreas infection	1/216 (0.5%)
Pneumonia	3/216 (1.4%)
Post procedural infection	1/216 (0.5%)
Pseudomonal bacteraemia	1/216 (0.5%)
Sepsis	6/216 (2.8%)
Septic embolus	1/216 (0.5%)
Septic shock	21/216 (9.7%)
Staphylococcal bacteraemia	1/216 (0.5%)
Urosepsis	1/216 (0.5%)
Injury, poisoning and procedural complications
Graft thrombosis	1/216 (0.5%)
Procedural complication	1/216 (0.5%)
Vascular pseudoaneurysm	1/216 (0.5%)
Wound dehiscence	1/216 (0.5%)
Investigations
Body temperature increased	1/216 (0.5%)
International normalised ratio increased	1/216 (0.5%)
Metabolism and nutrition disorders
Hyperglycaemia	1/216 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/216 (0.5%)
Bone neoplasm malignant	1/216 (0.5%)
Lymphoma	1/216 (0.5%)
Metastasis	1/216 (0.5%)
Oesophageal carcinoma	1/216 (0.5%)
Pancreatic carcinoma	1/216 (0.5%)
Nervous system disorders
Cerebral ischaemia	1/216 (0.5%)
Convulsion	2/216 (0.9%)
Hemiparesis	1/216 (0.5%)
Nervous system disorder	1/216 (0.5%)
Neurological symptom	1/216 (0.5%)
Polyneuropathy	1/216 (0.5%)
Somnolence	1/216 (0.5%)
Renal and urinary disorders
Renal failure	6/216 (2.8%)
Renal failure acute	1/216 (0.5%)
Urinary bladder haemorrhage	1/216 (0.5%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	2/216 (0.9%)
Acute respiratory failure	2/216 (0.9%)
Bronchospasm	1/216 (0.5%)
Hypoxia	2/216 (0.9%)
Pneumothorax	2/216 (0.9%)
Pulmonary embolism	2/216 (0.9%)
Pulmonary oedema	1/216 (0.5%)
Respiratory distress	1/216 (0.5%)
Respiratory failure	9/216 (4.2%)
Skin and subcutaneous tissue disorders
Erythema	1/216 (0.5%)
Surgical and medical procedures
Abdominal operation	5/216 (2.3%)
Amputation revision	1/216 (0.5%)
Debridement	1/216 (0.5%)
Vascular disorders
Circulatory collapse	2/216 (0.9%)
Haemorrhage	1/216 (0.5%)
Hypotension	2/216 (0.9%)
Shock	1/216 (0.5%)
Shock haemorrhagic	2/216 (0.9%)
Other (Not Including Serious) Adverse Events
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	78/216 (36.1%)
Blood and lymphatic system disorders
Anaemia	16/216 (7.4%)
Thrombocytopenia	11/216 (5.1%)
Cardiac disorders
Atrial fibrillation	11/216 (5.1%)
Tachycardia	11/216 (5.1%)
Gastrointestinal disorders
Diarrhoea	20/216 (9.3%)
Nausea	12/216 (5.6%)
General disorders
Pyrexia	12/216 (5.6%)
Vascular disorders
Hypertension	16/216 (7.4%)
Hypotension	15/216 (6.9%)

Limitations/Caveats

In a change to the protocol, time to first negative blood/tissue culture will only concern time to first negative blood culture. Lack of regular tissue sampling meant that analysis of time to first tissue culture could not be meaningfully performed.

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.