An Evaluation Of The Effectiveness And Safety Of Anidulaf... | NCT00805740

Label	Type	Description	Intervention Names
Anidulafungin arm	Experimental		Drug: Active anidulafungin
Caspofungin arm	Experimental		Drug: Active Caspofungin

Name	Type	Description	Arm Group Labels	Other Names
Active anidulafungin	Drug	Subjects in this arm will receive active anidulafungin and placebo caspofungin	Anidulafungin arm

Measure	Description	Time Frame
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)	Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.	End of Treatment (Day 14 to Day 42)

Measure	Description	Time Frame
Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit	Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Newark	Delaware	19713	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
33891293	Derived	De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
31280481	Derived

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)

Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.

Modified Intent-To-Treat (MITT) population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species (sp.).

Posted

Number

95% Confidence Interval

percentage of participants

End of Treatment (Day 14 to Day 42)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Units	Counts
Participants	OG00024 OG00113

Title

Denominators

Categories

Title	Measurements
	OG00083.3(62.6 to 95.3) OG00161.5(31.6 to 86.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.					Risk Difference (RD)	21.8			2-Sided	95	-12.3	53.3				No	Superiority or Other

Secondary

Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit

MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species. Only participants who completed therapy or who had global response of failure at EOT were evaluable for 2- and 6-week follow-up analysis.

Posted

Number

95% Confidence Interval

percentage of participants

2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Secondary

Percentage of Participants With Response Based on Clinical Cure and Microbiological Success

A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.

MITT population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Posted

Number

percentage of participants

EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin

Secondary

Percentage of Participants With Clinical Response

A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.

MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.

Posted

Number

95% Confidence Interval

percentage of participants

Day 10

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Secondary

Percentage of Participants With Relapse

Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.

MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.

Posted

Number

percentage of participants

2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Secondary

Percentage of Participants With New Infection

New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.

MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.

Posted

Number

percentage of participants

2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Secondary

Time to Negative Blood Culture

Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.

A sub-set of MITT population included only those participants who had a positive blood culture for Candida species at baseline.

Posted

Median

Full Range

days

Baseline up to 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Secondary

Percentage of Participants With All-cause Mortality

All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.

Safety analysis set included all randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Secondary

Time to Death

Time to death (days) was assessed as date of death minus first treatment date plus 1.

Safety analysis set included all randomized participants who received at least 1 dose of study drug.

Posted

Median

Full Range

days

Baseline up to 6-week follow-up (6 weeks after EOT)

ID	Title	Description
OG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
OG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0013 affected13 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0012 affected13 at risk
Bradycardia	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected13 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Eye disorder	Eye disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Eye haemorrhage	Eye disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Pupils unequal	Eye disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0003 affected26 at risk EG0011 affected13 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0012 affected13 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0013 affected13 at risk
Chest pain	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Inflammation	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Multi-organ failure	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Oedema	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected13 at risk
Oedema peripheral	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Pyrexia	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Abdominal abscess	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Abscess	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Acinetobacter infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Candidiasis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Clostridium colitis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Enterococcal infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Haematoma infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Peritoneal candidiasis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0003 affected26 at risk EG0012 affected13 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Sepsis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Septic shock	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Skin infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Staphylococcal infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Superinfection bacterial	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Pancreatic leak	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Weaning failure	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Wound contamination	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Aspergillus test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Bacterial test	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Bacterial test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected13 at risk
Bacteroides test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0003 affected26 at risk EG0012 affected13 at risk
Blood bilirubin increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Blood culture negative	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Blood magnesium decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Blood potassium decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0012 affected13 at risk
Blood triglycerides increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
C-reactive protein increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Citrobacter test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Corynebacterium test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Cytomegalovirus test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Enterobacter test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Enterococcus test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Escherichia test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Fungal test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Haematocrit decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected13 at risk
Klebsiella test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Oxygen saturation decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Platelet count increased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Proteus test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Prothrombin time prolonged	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Pseudomonas test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Staphylococcus test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0013 affected13 at risk
Stenotrophomonas test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Streptococcus test positive	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0013 affected13 at risk
Urine output decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Weight decreased	Investigations	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected13 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Dyskinesia	Nervous system disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Headache	Nervous system disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected13 at risk
Nervous system disorder	Nervous system disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Anxiety	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Catatonia	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Confusional state	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Delirium	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Depression	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected13 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Sleep disorder	Psychiatric disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Urinoma	Renal and urinary disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0014 affected13 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected13 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Haematoma	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Haemodynamic instability	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0004 affected26 at risk EG0012 affected13 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0003 affected26 at risk EG0013 affected13 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Phlebitis	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0012 affected13 at risk
Shock	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected13 at risk

ID	Term
D002177	Candidiasis
D016469	Fungemia
D058365	Candidiasis, Invasive
C536972	Torulopsis
D058387	Candidemia
D009181	Mycoses

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000072742	Invasive Fungal Infections
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
BG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Anidulafungin	Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).			12	26	23	26
EG001	Caspofungin	Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).			7	13	11	13

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Bradycardia	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected13 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected13 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
General physical health deterioration	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Injury associated with device	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Multi-organ failure	General disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Abdominal infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Abdominal sepsis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Infectious peritonitis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Nosocomial infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Peptostreptococcus infection	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Peritonitis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Septic shock	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Tracheobronchitis	Infections and infestations	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Splenic haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected13 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected13 at risk