Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.

Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.

Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.

An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).

Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.

Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).

Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.

Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.

Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.