Trial Outcomes & Findings for Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (NCT NCT03667690)

Last Updated: 2023-01-06

Results Overview

The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

199 participants

Primary outcome timeframe

Day 30 (-2 days)

Results posted on

2023-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Rezafungin for Injection Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Overall Study STARTED	100	99
Overall Study Completed Study Drug Regimen Through Study Day 14	66	71
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	41	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Rezafungin for Injection Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Overall Study Adverse Event	0	3
Overall Study Death	22	21
Overall Study Lost to Follow-up	4	5
Overall Study Withdrawal by Subject	7	8
Overall Study Subject could not return for additional investigational product	1	0
Overall Study Subject discharged to hospice care	2	0
Overall Study Withdrawal of consent by subject's legally authorized representative; subject placed in hospice	1	0
Overall Study Study visit missed or conducted over the phone due to Coronavirus disease 2019 (COVID-19) pandemic	2	1
Overall Study Diagnosis of other types of invasive candidiasis	1	1
Overall Study Subject was dropped due to exclusion criterion number 9	1	0
Overall Study Per Medical Monitor, visits performed over the phone were to be considered as early discontinuation	0	1

Baseline Characteristics

Data was not captured for all subjects, as some subjects did not have weight determined at Screening.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Rezafungin for Injection n=100 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=99 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline	Total n=199 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=100 Participants	0 Participants n=99 Participants	0 Participants n=199 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=100 Participants	58 Participants n=99 Participants	118 Participants n=199 Participants
Age, Categorical >=65 years	40 Participants n=100 Participants	41 Participants n=99 Participants	81 Participants n=199 Participants
Age, Continuous	59.0 years n=100 Participants	62.0 years n=99 Participants	61.0 years n=199 Participants
Sex: Female, Male Female	33 Participants n=100 Participants	43 Participants n=99 Participants	76 Participants n=199 Participants
Sex: Female, Male Male	67 Participants n=100 Participants	56 Participants n=99 Participants	123 Participants n=199 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=100 Participants	4 Participants n=99 Participants	11 Participants n=199 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=100 Participants	94 Participants n=99 Participants	183 Participants n=199 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=100 Participants	1 Participants n=99 Participants	5 Participants n=199 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=100 Participants	1 Participants n=99 Participants	2 Participants n=199 Participants
Race (NIH/OMB) Asian	27 Participants n=100 Participants	31 Participants n=99 Participants	58 Participants n=199 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=100 Participants	0 Participants n=99 Participants	0 Participants n=199 Participants
Race (NIH/OMB) Black or African American	5 Participants n=100 Participants	4 Participants n=99 Participants	9 Participants n=199 Participants
Race (NIH/OMB) White	61 Participants n=100 Participants	60 Participants n=99 Participants	121 Participants n=199 Participants
Race (NIH/OMB) More than one race	0 Participants n=100 Participants	0 Participants n=99 Participants	0 Participants n=199 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=100 Participants	3 Participants n=99 Participants	9 Participants n=199 Participants
Region of Enrollment Australia	8 participants n=100 Participants	5 participants n=99 Participants	13 participants n=199 Participants
Region of Enrollment Belgium	5 participants n=100 Participants	7 participants n=99 Participants	12 participants n=199 Participants
Region of Enrollment Bulgaria	6 participants n=100 Participants	4 participants n=99 Participants	10 participants n=199 Participants
Region of Enrollment China	6 participants n=100 Participants	5 participants n=99 Participants	11 participants n=199 Participants
Region of Enrollment Colombia	1 participants n=100 Participants	0 participants n=99 Participants	1 participants n=199 Participants
Region of Enrollment France	5 participants n=100 Participants	1 participants n=99 Participants	6 participants n=199 Participants
Region of Enrollment Greece	6 participants n=100 Participants	11 participants n=99 Participants	17 participants n=199 Participants
Region of Enrollment Israel	3 participants n=100 Participants	2 participants n=99 Participants	5 participants n=199 Participants
Region of Enrollment Italy	2 participants n=100 Participants	3 participants n=99 Participants	5 participants n=199 Participants
Region of Enrollment Singapore	3 participants n=100 Participants	0 participants n=99 Participants	3 participants n=199 Participants
Region of Enrollment South Korea	6 participants n=100 Participants	6 participants n=99 Participants	12 participants n=199 Participants
Region of Enrollment Spain	12 participants n=100 Participants	12 participants n=99 Participants	24 participants n=199 Participants
Region of Enrollment Taiwan	3 participants n=100 Participants	1 participants n=99 Participants	4 participants n=199 Participants
Region of Enrollment Thailand	8 participants n=100 Participants	17 participants n=99 Participants	25 participants n=199 Participants
Region of Enrollment United States	26 participants n=100 Participants	25 participants n=99 Participants	51 participants n=199 Participants
Weight	68.00 kilograms n=95 Participants • Data was not captured for all subjects, as some subjects did not have weight determined at Screening.	66.20 kilograms n=91 Participants • Data was not captured for all subjects, as some subjects did not have weight determined at Screening.	67.90 kilograms n=186 Participants • Data was not captured for all subjects, as some subjects did not have weight determined at Screening.
Height	170.00 centimeters n=94 Participants • Data was not captured for all subjects, as some subjects did not have height determined at Screening.	168.00 centimeters n=90 Participants • Data was not captured for all subjects, as some subjects did not have height determined at Screening.	168.00 centimeters n=184 Participants • Data was not captured for all subjects, as some subjects did not have height determined at Screening.
Body Mass Index (BMI)	23.63 kilograms/meter^2 n=94 Participants • Data was not captured for all subjects, as some subjects did not have BMI calculated at Screening.	24.07 kilograms/meter^2 n=88 Participants • Data was not captured for all subjects, as some subjects did not have BMI calculated at Screening.	24.02 kilograms/meter^2 n=182 Participants • Data was not captured for all subjects, as some subjects did not have BMI calculated at Screening.
Diagnosis Candidemia only	70 Participants n=100 Participants	68 Participants n=99 Participants	138 Participants n=199 Participants
Diagnosis Invasive candidiasis	30 Participants n=100 Participants	31 Participants n=99 Participants	61 Participants n=199 Participants
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score Category ≥20	15 Participants n=100 Participants	18 Participants n=99 Participants	33 Participants n=199 Participants
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score Category 10-19	43 Participants n=100 Participants	44 Participants n=99 Participants	87 Participants n=199 Participants
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score Category 0-9	41 Participants n=100 Participants	37 Participants n=99 Participants	78 Participants n=199 Participants
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score Category Missing	1 Participants n=100 Participants	0 Participants n=99 Participants	1 Participants n=199 Participants
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score	12.0 units on a scale n=99 Participants • Data was not captured for all subjects, as some subjects did not have the modified APACHE II calculation performed.	12.0 units on a scale n=99 Participants • Data was not captured for all subjects, as some subjects did not have the modified APACHE II calculation performed.	12.0 units on a scale n=198 Participants • Data was not captured for all subjects, as some subjects did not have the modified APACHE II calculation performed.
Absolute Neutrophil Count (ANC) (per microliter) at Baseline <500/μL	9 Participants n=100 Participants	6 Participants n=99 Participants	15 Participants n=199 Participants
Absolute Neutrophil Count (ANC) (per microliter) at Baseline ≥500/μL	88 Participants n=100 Participants	93 Participants n=99 Participants	181 Participants n=199 Participants
Absolute Neutrophil Count (ANC) (per microliter) at Baseline Missing	3 Participants n=100 Participants	0 Participants n=99 Participants	3 Participants n=199 Participants
Modified APACHE II Score/ANC APACHE II score ≥20 or ANC <500/μL	22 Participants n=100 Participants	21 Participants n=99 Participants	43 Participants n=199 Participants
Modified APACHE II Score/ANC APACHE II score <20 and ANC ≥500/μL	75 Participants n=100 Participants	78 Participants n=99 Participants	153 Participants n=199 Participants
Modified APACHE II Score/ANC Missing	3 Participants n=100 Participants	0 Participants n=99 Participants	3 Participants n=199 Participants
Randomization Strata Candidemia only, APACHE II score ≥20 or ANC <500/μL	19 Participants n=100 Participants	17 Participants n=99 Participants	36 Participants n=199 Participants
Randomization Strata Candidemia only, APACHE II score <20 and ANC ≥500/μL	51 Participants n=100 Participants	53 Participants n=99 Participants	104 Participants n=199 Participants
Randomization Strata Invasive candidiasis, APACHE II score ≥20 or ANC <500/μL	5 Participants n=100 Participants	5 Participants n=99 Participants	10 Participants n=199 Participants
Randomization Strata Invasive candidiasis, APACHE II score <20 and ANC ≥500/μL	25 Participants n=100 Participants	24 Participants n=99 Participants	49 Participants n=199 Participants
Estimated Creatinine Clearance	78.43 milliliters (mL)/minute n=94 Participants • Data was not captured for all subjects, as some subjects did not have the creatinine clearance calculation performed.	64.93 milliliters (mL)/minute n=88 Participants • Data was not captured for all subjects, as some subjects did not have the creatinine clearance calculation performed.	72.01 milliliters (mL)/minute n=182 Participants • Data was not captured for all subjects, as some subjects did not have the creatinine clearance calculation performed.
Child-Pugh Score Category <7	0 Participants n=100 Participants	0 Participants n=99 Participants	0 Participants n=199 Participants
Child-Pugh Score Category 7-9	2 Participants n=100 Participants	6 Participants n=99 Participants	8 Participants n=199 Participants
Child-Pugh Score Category No History of Liver Disease/Not Calculated	98 Participants n=100 Participants	93 Participants n=99 Participants	191 Participants n=199 Participants

PRIMARY outcome

Timeframe: Day 30 (-2 days)

Population: The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug.

The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
All-Cause Mortality (US FDA Only) Deceased: Known Deceased (subjects who died on or before Day 30)	19 Participants	17 Participants
All-Cause Mortality (US FDA Only) Deceased: Unknown Survival Status	3 Participants	3 Participants
All-Cause Mortality (US FDA Only) Alive	71 Participants	74 Participants

PRIMARY outcome

Timeframe: Day 14 (±1 day)

The number and percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure \[for qualifying invasive candidiasis subjects at baseline\], and mycological eradication, as confirmed by the Data Review Committee \[DRC\]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) Cure	55 Participants	57 Participants
Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) Failure	28 Participants	29 Participants
Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) Indeterminate	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 14 (±1 day)

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Global Response as Assessed by Data Review Committee (US FDA Only) Cure	55 Participants	57 Participants
Global Response as Assessed by Data Review Committee (US FDA Only) Failure	28 Participants	29 Participants
Global Response as Assessed by Data Review Committee (US FDA Only) Indeterminate	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 30 (-2 days)

The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
All-Cause Mortality (EU EMA Only) Deceased: Known Deceased (subjects who died on or before Day 30)	19 Participants	17 Participants
All-Cause Mortality (EU EMA Only) Deceased: Unknown Survival Status	3 Participants	3 Participants
All-Cause Mortality (EU EMA Only) Alive	71 Participants	74 Participants

SECONDARY outcome

Timeframe: Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59)

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Comparison of Global Response (as Assessed by the DRC) by Visit Day 5 · Cure	52 Participants	49 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Day 5 · Failure	32 Participants	37 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Day 5 · Indeterminate	9 Participants	8 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Day 30 (-2 days) · Cure	46 Participants	46 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Day 30 (-2 days) · Failure	31 Participants	36 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Day 30 (-2 days) · Indeterminate	16 Participants	12 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit EOT (≤2 days of last dose) · Cure	56 Participants	59 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit EOT (≤2 days of last dose) · Failure	29 Participants	32 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit EOT (≤2 days of last dose) · Indeterminate	8 Participants	3 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Follow-up (Days 52-59) · Cure	42 Participants	39 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Follow-up (Days 52-59) · Failure	38 Participants	42 Participants
Comparison of Global Response (as Assessed by the DRC) by Visit Follow-up (Days 52-59) · Indeterminate	13 Participants	13 Participants

SECONDARY outcome

Timeframe: Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)

The number and percentage of subjects in each treatment group who have a mycological response of eradication, failure, or indeterminate in the mITT population. A mycological response of eradication means clearance of objective evidence of infection and is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was eradication or failure. Definitions for the mycological responses of eradication, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 8 (Mycological Response) of the clinical protocol. Note: Eradication includes both documented and presumed eradication.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Comparison of Mycological Eradication by Visit Day 5 · Eradication	64 Participants	58 Participants
Comparison of Mycological Eradication by Visit Day 5 · Failure	25 Participants	27 Participants
Comparison of Mycological Eradication by Visit Day 5 · Indeterminate	4 Participants	9 Participants
Comparison of Mycological Eradication by Visit Day 14 (±1 day) · Eradication	63 Participants	62 Participants
Comparison of Mycological Eradication by Visit Day 14 (±1 day) · Failure	26 Participants	28 Participants
Comparison of Mycological Eradication by Visit Day 14 (±1 day) · Indeterminate	4 Participants	4 Participants
Comparison of Mycological Eradication by Visit Day 30 (-2 days) · Eradication	56 Participants	53 Participants
Comparison of Mycological Eradication by Visit Day 30 (-2 days) · Failure	33 Participants	38 Participants
Comparison of Mycological Eradication by Visit Day 30 (-2 days) · Indeterminate	4 Participants	3 Participants
Comparison of Mycological Eradication by Visit EOT (≤2 days of last dose) · Eradication	63 Participants	63 Participants
Comparison of Mycological Eradication by Visit EOT (≤2 days of last dose) · Failure	26 Participants	29 Participants
Comparison of Mycological Eradication by Visit EOT (≤2 days of last dose) · Indeterminate	4 Participants	2 Participants
Comparison of Mycological Eradication by Visit Follow-up (Days 52-59) · Eradication	48 Participants	49 Participants
Comparison of Mycological Eradication by Visit Follow-up (Days 52-59) · Failure	41 Participants	43 Participants
Comparison of Mycological Eradication by Visit Follow-up (Days 52-59) · Indeterminate	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)

The number and percentage of subjects in each treatment group for whom the Investigator determined a clinical response of cure, failure, or indeterminate in the mITT population. A clinical response of cure, as assessed by the Investigator, is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the clinical responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 9 (Investigator's Assessment of Clinical Response) of the clinical protocol.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=93 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=94 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Comparison of Investigators' Assessment of Clinical Response by Visit Day 5 · Cure	59 Participants	70 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 5 · Failure	31 Participants	22 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 5 · Indeterminate	3 Participants	2 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 14 (±1 day) · Cure	62 Participants	63 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 14 (±1 day) · Failure	26 Participants	27 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 14 (±1 day) · Indeterminate	5 Participants	4 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 30 (-2 days) · Cure	51 Participants	52 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 30 (-2 days) · Failure	32 Participants	34 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Day 30 (-2 days) · Indeterminate	10 Participants	8 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit EOT (≤2 days of last dose) · Cure	65 Participants	64 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit EOT (≤2 days of last dose) · Failure	22 Participants	26 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit EOT (≤2 days of last dose) · Indeterminate	6 Participants	4 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Follow-up (Days 52-59) · Cure	46 Participants	44 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Follow-up (Days 52-59) · Failure	38 Participants	40 Participants
Comparison of Investigators' Assessment of Clinical Response by Visit Follow-up (Days 52-59) · Indeterminate	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59)

The number and percentage of subjects with invasive candidiasis (documented by radiologic/imaging evidence at baseline) in each treatment group who have a radiological response (as assessed by the Investigator) of cure, failure, and indeterminate in the mITT population. A radiological response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the radiological responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 10 (Radiological Response) of the clinical protocol.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=17 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=17 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Comparison of Radiological Response by Investigator by Visit Day 5 · Cure	4 Participants	6 Participants
Comparison of Radiological Response by Investigator by Visit Day 5 · Failure	2 Participants	2 Participants
Comparison of Radiological Response by Investigator by Visit Day 5 · Indeterminate	9 Participants	9 Participants
Comparison of Radiological Response by Investigator by Visit Day 14 (±1 day) · Cure	11 Participants	10 Participants
Comparison of Radiological Response by Investigator by Visit Day 14 (±1 day) · Failure	2 Participants	6 Participants
Comparison of Radiological Response by Investigator by Visit Day 14 (±1 day) · Indeterminate	4 Participants	1 Participants
Comparison of Radiological Response by Investigator by Visit Day 30 (-2 days) · Cure	10 Participants	11 Participants
Comparison of Radiological Response by Investigator by Visit Day 30 (-2 days) · Failure	4 Participants	6 Participants
Comparison of Radiological Response by Investigator by Visit Day 30 (-2 days) · Indeterminate	3 Participants	0 Participants
Comparison of Radiological Response by Investigator by Visit EOT (≤2 days of last dose) · Cure	9 Participants	11 Participants
Comparison of Radiological Response by Investigator by Visit EOT (≤2 days of last dose) · Failure	2 Participants	6 Participants
Comparison of Radiological Response by Investigator by Visit EOT (≤2 days of last dose) · Indeterminate	5 Participants	0 Participants
Comparison of Radiological Response by Investigator by Visit Follow-up (Days 52-59) · Cure	12 Participants	10 Participants
Comparison of Radiological Response by Investigator by Visit Follow-up (Days 52-59) · Failure	3 Participants	7 Participants
Comparison of Radiological Response by Investigator by Visit Follow-up (Days 52-59) · Indeterminate	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Follow-up Visit (Days 52-59)

Population: The Safety Population includes all subjects who received any amount of the study drug. Safety analyses were performed on the Safety Population. Subjects who received the wrong study drug for their entire course of study drug were analyzed in the treatment group based on the drug received. Subjects who received the wrong study drug for part of their course of study drug were analyzed in the treatment group based on majority of (i.e., most frequent) doses received.

The number and percentage of subjects in each treatment group that experienced at least one treatment-emergent adverse event (TEAE) based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and electrocardiogram (ECG) abnormalities. Notes: A subject with multiple adverse events (AEs) was counted only once. TEAE was defined as an AE that occurred during or after study drug administration and up through the Follow-up visit. The maximum severity and strongest relationship were counted for subjects with multiple events.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=98 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=98 Participants Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one TEAE	89 Participants	83 Participants
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one TEAE up through Day 7	68 Participants	61 Participants
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one study drug-related TEAE	16 Participants	9 Participants
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one grade 4/5 TEAE	36 Participants	37 Participants
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one TEAE leading to interruption of study drug	3 Participants	1 Participants
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one TEAE leading to discontinuation of study drug	13 Participants	11 Participants
Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] At least one TEAE leading to study discontinuation	20 Participants	17 Participants

SECONDARY outcome

Timeframe: Day 1, 10 minutes before the end of infusion

Population: The Pharmacokinetic (PK) Population includes all subjects who received any amount of study drug and had at least one blood sample with measurable concentrations. Note: Although blood samples were collected from all subjects receiving study drug, only PK samples from subjects receiving rezafungin for injection were analyzed.

Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=86 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Evaluate Pharmacokinetics (Cmax)	24.18 micrograms/milliliter Standard Deviation 32.497	—

SECONDARY outcome

Timeframe: Day 8, pre-dose, within 30 minutes prior to the start of infusion

Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=65 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Evaluate Pharmacokinetics (Cmin)	2.94 micrograms/milliliter Standard Deviation 2.656	—

SECONDARY outcome

Timeframe: Day 15, pre-dose, within 30 minutes prior to the start of infusion

Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=16 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Evaluate Pharmacokinetics (Cmin)	2.81 micrograms/milliliter Standard Deviation 1.378	—

SECONDARY outcome

Timeframe: Day 22, pre-dose, within 30 minutes prior to the start of infusion

Evaluate the minimum plasma concentration (Cmin) of rezafungin for injection.

Outcome measures

Outcome measures
Measure	Group 1: Rezafungin for Injection n=5 Participants Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
Evaluate Pharmacokinetics (Cmin)	3.74 micrograms/milliliter Standard Deviation 1.948	—

Adverse Events

Group 1: Rezafungin for Injection

Serious events: 55 serious events

Other events: 90 other events

Deaths: 29 deaths

Group 2: Caspofungin

Serious events: 52 serious events

Other events: 66 other events

Deaths: 25 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Rezafungin for Injection n=98 participants at risk Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. Rezafungin for Injection: Intravenous antifungal therapy oral placebo: Microcrystalline cellulose	Group 2: Caspofungin n=98 participants at risk Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: Oral antifungal therapy intravenous placebo: Normal saline
General disorders Pyrexia	14.3% 14/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	5.1% 5/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	12.2% 12/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	9.2% 9/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Blood and lymphatic system disorders Anaemia	9.2% 9/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	9.2% 9/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Metabolism and nutrition disorders Hypomagnesaemia	7.1% 7/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	3.1% 3/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Diarrhoea	6.1% 6/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	7.1% 7/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Infections and infestations Pneumonia	6.1% 6/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	1.0% 1/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Vomiting	6.1% 6/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	2.0% 2/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Abdominal pain	5.1% 5/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	4.1% 4/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Constipation	5.1% 5/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	3.1% 3/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Metabolism and nutrition disorders Hypophosphataemia	5.1% 5/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	4.1% 4/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Nausea	5.1% 5/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	2.0% 2/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Vascular disorders Hypotension	4.1% 4/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	6.1% 6/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Infections and infestations Urinary tract infection	4.1% 4/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	6.1% 6/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.
Renal and urinary disorders Acute kidney injury	2.0% 2/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.	5.1% 5/98 • Deaths and adverse events (AEs) were monitored and recorded from the time a subject signed the informed consent form (ICF) through the Follow-up visit (Days 52-59). Non-treatment-emergent adverse events were AEs occurring prior to dosing; treatment-emergent adverse events (TEAEs) were AEs that occurred during or at any time after dosing. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all subjects who received any amount of the study drug. All safety analyses were performed by actual treatment received.

Additional Information

Taylor Sandison, M.D., MPH

Cidara Therapeutics, Inc.

Phone: 858-888-7868

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER