Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (NCT NCT03059992)

Last Updated: 2024-11-20

Results Overview

The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

233 participants

Primary outcome timeframe

Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

Results posted on

2024-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Ibrexafungerp (SCY-078) Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Overall Study STARTED	233
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	109

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
Age, Continuous	53.6 years STANDARD_DEVIATION 16.23 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	219 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants
Race (NIH/OMB) White	180 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.

Population: Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug. Per Protocol (PP) Population - include all ITT participants who received enough study drug to enable clinical efficacy judgement as determined by the DRC, who have an EOT or TOC (as applicable) assessment and who have no major protocol violations that could impact the assessment of efficacy.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Invasive Candidiasis (ITT) · Not Evaluable	4 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Invasive Candidiasis (PP) · Failure	7 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Esophageal Candidiasis (PP) · Failure	4 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Oropharyngeal Candidiasis (ITT) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Other Emerging Fungi (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Mucocutaneous Candidiasis (ITT) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Mucocutaneous Candidiasis (PP) · Success	8 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Mucocutaneous Candidiasis (PP) · Failure	4 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Mucocutaneous Candidiasis (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Vulvovaginal Candidiasis (ITT) · Success	26 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Vulvovaginal Candidiasis (ITT) · Failure	4 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Vulvovaginal Candidiasis (ITT) · Not Evaluable	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Vulvovaginal Candidiasis (PP) · Success	24 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Vulvovaginal Candidiasis (PP) · Failure	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Vulvovaginal Candidiasis (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Disseminated/Invasive Dimorphic Fungi (ITT) · Success	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Disseminated/Invasive Dimorphic Fungi (ITT) · Failure	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Disseminated/Invasive Dimorphic Fungi (ITT) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Disseminated/Invasive Dimorphic Fungi (PP) · Success	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Disseminated/Invasive Dimorphic Fungi (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Disseminated/Invasive Dimorphic Fungi (PP) · Failure	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Pulmonary Aspergillosis (ITT) · Success	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Pulmonary Aspergillosis (ITT) · Failure	6 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Pulmonary Aspergillosis (ITT) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Pulmonary Aspergillosis (PP) · Success	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Pulmonary Aspergillosis (PP) · Failure	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Pulmonary Aspergillosis (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Allergic Bronchopulmonary Aspergillosis (ITT) · Success	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Allergic Bronchopulmonary Aspergillosis (ITT) · Not Evaluable	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Allergic Bronchopulmonary Aspergillosis (ITT) · Failure	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Allergic Bronchopulmonary Aspergillosis (PP) · Success	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Allergic Bronchopulmonary Aspergillosis (PP) · Failure	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Oropharyngeal Candidiasis (PP) · Failure	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Oropharyngeal Candidiasis (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Mucocutaneous Candidiasis (ITT) · Success	8 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Mucocutaneous Candidiasis (ITT) · Failure	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Overall Study (ITT) · Success	142 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Overall Study (ITT) · Failure	69 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Overall Study (ITT) · Not Evaluable	22 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Overall Study (PP) · Success	131 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Overall Study (PP) · Failure	59 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Overall Study (PP) · Not Evaluable	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Acute Invasive Candidiasis including Candidemia (ITT) · Success	40 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Acute Invasive Candidiasis including Candidemia (ITT) · Failure	13 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Acute Invasive Candidiasis including Candidemia (ITT) · Not Evaluable	8 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Acute Invasive Candidiasis including Candidemia (PP) · Success	37 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Acute Invasive Candidiasis including Candidemia (PP) · Failure	10 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Acute Invasive Candidiasis including Candidemia (PP) · Not Evaluable	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Invasive Candidiasis (ITT) · Success	30 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Invasive Candidiasis (ITT) · Failure	9 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Invasive Candidiasis (PP) · Success	25 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Chronic Invasive Candidiasis (PP) · Not Evaluable	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Esophageal Candidiasis (ITT) · Success	9 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Esophageal Candidiasis (ITT) · Failure	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Esophageal Candidiasis (ITT) · Not Evaluable	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Esophageal Candidiasis (PP) · Success	9 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Esophageal Candidiasis (PP) · Not Evaluable	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Oropharyngeal Candidiasis (ITT) · Success	9 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Oropharyngeal Candidiasis (ITT) · Failure	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Allergic Bronchopulmonary Aspergillosis (PP) · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Invasive Pulmonary Aspergillosis (ITT) · Success	12 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Invasive Pulmonary Aspergillosis (ITT) · Failure	14 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Invasive Pulmonary Aspergillosis (ITT) · Not Evaluable	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Invasive Pulmonary Aspergillosis (PP) · Success	12 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Invasive Pulmonary Aspergillosis (PP) · Failure	13 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Invasive Pulmonary Aspergillosis (PP) · Not Evaluable	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Other Emerging Fungi (ITT) · Success	7 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Other Emerging Fungi (ITT) · Failure	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Other Emerging Fungi (ITT) · Not Evaluable	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Other Emerging Fungi (PP) · Success	7 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Other Emerging Fungi (PP) · Failure	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. Oropharyngeal Candidiasis (PP) · Success	8 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.

The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Relapse · Success	12 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Relapse · Failure	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Relapse · Not Evaluable	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Other · Success	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Other · Failure	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Other · Not Evaluable	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Refractory Fungal Infection · Success	74 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Refractory Fungal Infection · Failure	41 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Refractory Fungal Infection · Not Evaluable	13 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Resistance to standard of care antifungal · Success	95 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Resistance to standard of care antifungal · Failure	29 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Resistance to standard of care antifungal · Not Evaluable	10 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Intolerance to standard of care antifungal · Success	13 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Intolerance to standard of care antifungal · Failure	14 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Intolerance to standard of care antifungal · Not Evaluable	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Toxicities associated with standard of care antifungal · Success	7 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Toxicities associated with standard of care antifungal · Failure	8 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category Toxicities associated with standard of care antifungal · Not Evaluable	2 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.

The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Invasive Candidiasis including Candidemia · Success	70 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Mucocutaneous Candidiasis · Failure	19 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Invasive Candidiasis including Candidemia · Failure	22 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Invasive Candidiasis including Candidemia · Not Evaluable	12 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Mucocutaneous Candidiasis · Success	52 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Mucocutaneous Candidiasis · Not Evaluable	4 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Dimorphic Fungi · Success	1 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Dimorphic Fungi · Failure	2 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Dimorphic Fungi · Not Evaluable	0 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Aspergillus Syndromes · Success	12 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Aspergillus Syndromes · Failure	23 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Aspergillus Syndromes · Not Evaluable	5 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Other emerging fungi · Success	7 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Other emerging fungi · Failure	3 Participants
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. Other emerging fungi · Not Evaluable	1 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Invasive Candidiasis including Candidemia · Success	57 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Invasive Candidiasis including Candidemia · Failure	16 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Invasive Candidiasis including Candidemia · Not Evaluable	29 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Invasive Candidiasis including Candidemia · No Response	2 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Mucocutaneous Candidiasis (TOC) · Success	25 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Mucocutaneous Candidiasis (TOC) · Failure	5 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Mucocutaneous Candidiasis (TOC) · Not Evaluable	2 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Mucocutaneous Candidiasis (TOC) · No Response	43 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Dimorphic Fungi · Success	3 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Dimorphic Fungi · Failure	0 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Dimorphic Fungi · Not Evaluable	0 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Dimorphic Fungi · No Response	0 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Aspergillus Syndromes · Success	18 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Aspergillus Syndromes · Failure	14 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Aspergillus Syndromes · Not Evaluable	6 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Aspergillus Syndromes · No Response	2 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Other emerging fungi · Success	7 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Other emerging fungi · Failure	3 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Other emerging fungi · Not Evaluable	1 Participants
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category Other emerging fungi · No Response	0 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. glabrata) · Success	30 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. glabrata) · Not Evaluable/Missing	13 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. tropicalis) · Success	6 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. tropicalis) · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. tropicalis) · Not Evaluable/Missing	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (other) · Success	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (other) · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. glabrata) · Failure	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. krusei) · Success	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. tropicalis) · Success	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. tropicalis) · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. tropicalis) · Not Evaluable/Missing	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. parapsilosis) · Success	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. parapsilosis) · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (other) · Success	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (other) · Failure	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Dimorphic Fungi (Histoplasmosis) · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (A. flavus) · Success	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (A. flavus) · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (A. flavus) · Not Evaluable/Missing	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. albicans) · Success	11 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. albicans) · Failure	7 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. albicans) · Not Evaluable/Missing	8 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. auris) · Success	6 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. auris) · Failure	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. auris) · Not Evaluable/Missing	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. glabrata) · Failure	6 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. krusei) · Success	4 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. krusei) · Failure	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. krusei) · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. parapsilosis) · Success	5 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. parapsilosis) · Failure	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. parapsilosis) · Not Evaluable/Missing	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (other) · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. albicans) · Success	19 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. albicans) · Failure	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. albicans) · Not Evaluable/Missing	27 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. glabrata) · Success	5 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. glabrata) · Not Evaluable/Missing	17 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. krusei) · Failure	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. krusei) · Not Evaluable/Missing	4 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (C. parapsilosis) · Not Evaluable/Missing	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Mucocutaneous Candidiasis (other) · Not Evaluable/Missing	5 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Dimorphic Fungi (Histoplasmosis) · Success	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Dimorphic Fungi (Histoplasmosis) · Not Evaluable/Missing	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (A. fumigatus) · Success	8 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (A. fumigatus) · Failure	8 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (A. fumigatus) · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (other) · Success	9 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (other) · Failure	5 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen Aspergillus Syndromes (other) · Not Evaluable/Missing	0 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Invasive Candidiasis · Failure	6 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Invasive Candidiasis · Not Evaluable	10 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Vulvovaginal Candidiasis · Success	25 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Vulvovaginal Candidiasis · Failure	5 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Vulvovaginal Candidiasis · Not Evaluable	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Vulvovaginal Candidiasis · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Esophageal Candidiasis · Failure	4 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Oropharyngeal Candidiasis · Failure	4 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Invasive Pulmonary Aspergillosis · Not Evaluable	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Esophageal Candidiasis · Success	10 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Acute Invasive Candidiasis, including Candidemia · Success	30 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Acute Invasive Candidiasis, including Candidemia · Failure	10 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Acute Invasive Candidiasis, including Candidemia · Not Evaluable	19 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Acute Invasive Candidiasis, including Candidemia · No Response	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Invasive Candidiasis · Success	27 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Invasive Candidiasis · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Other Emerging Fungi · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Esophageal Candidiasis · Not Evaluable	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Esophageal Candidiasis · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Oropharyngeal Candidiasis · Success	10 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Oropharyngeal Candidiasis · Not Evaluable	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Oropharyngeal Candidiasis · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Mucocutaneous Candidiasis · Success	8 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Mucocutaneous Candidiasis · Failure	5 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Mucocutaneous Candidiasis · Not Evaluable	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Mucocutaneous Candidiasis · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Disseminated/Invasive Dimorphic Fungi · Success	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Disseminated/Invasive Dimorphic Fungi · Failure	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Disseminated/Invasive Dimorphic Fungi · Not Evaluable	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Disseminated/Invasive Dimorphic Fungi · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Pulmonary Aspergillosis · Success	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Pulmonary Aspergillosis · Failure	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Pulmonary Aspergillosis · Not Evaluable	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Chronic Pulmonary Aspergillosis · No Response	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Allergic Bronchopulmonary Aspergillosis · Success	0 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Allergic Bronchopulmonary Aspergillosis · Failure	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Allergic Bronchopulmonary Aspergillosis · Not Evaluable	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Allergic Bronchopulmonary Aspergillosis · No Response	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Invasive Pulmonary Aspergillosis · Success	15 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Invasive Pulmonary Aspergillosis · Failure	10 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Invasive Pulmonary Aspergillosis · No Response	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Other Emerging Fungi · Success	7 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Other Emerging Fungi · Failure	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease Other Emerging Fungi · Not Evaluable	1 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Toxicities · Failure	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Refractory · Success	57 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Refractory · Failure	29 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Refractory · Not Evaluable	13 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Refractory · No Response	29 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Resistence · Success	75 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Resistence · Failure	23 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Resistence · Not Evaluable	25 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Resistence · No Response	11 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Intolerance · Success	16 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Intolerance · Failure	8 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Intolerance · Not Evaluable	3 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Intolerance · No Response	2 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Toxicities · Success	12 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Toxicities · Not Evaluable	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Toxicities · No Response	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Relapse · Success	8 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Relapse · Failure	4 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Relapse · Not Evaluable	1 Participants
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category Relapse · No Response	5 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Mycological Response by Disease Category Invasive Candidiasis including Candidemia · Success	20 Participants
Percentage of Participants With a Mycological Response by Disease Category Invasive Candidiasis including Candidemia · Failure	14 Participants
Percentage of Participants With a Mycological Response by Disease Category Invasive Candidiasis including Candidemia · Not Evaluable/Missing	70 Participants
Percentage of Participants With a Mycological Response by Disease Category Mucocutaneous Candidiasis (TOC) · Success	11 Participants
Percentage of Participants With a Mycological Response by Disease Category Mucocutaneous Candidiasis (TOC) · Failure	13 Participants
Percentage of Participants With a Mycological Response by Disease Category Mucocutaneous Candidiasis (TOC) · Not Evaluable/Missing	51 Participants
Percentage of Participants With a Mycological Response by Disease Category Dimorphic Fungi · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category Dimorphic Fungi · Failure	1 Participants
Percentage of Participants With a Mycological Response by Disease Category Dimorphic Fungi · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Mycological Response by Disease Category Aspergillus Syndromes · Success	5 Participants
Percentage of Participants With a Mycological Response by Disease Category Aspergillus Syndromes · Failure	13 Participants
Percentage of Participants With a Mycological Response by Disease Category Aspergillus Syndromes · Not Evaluable/Missing	22 Participants
Percentage of Participants With a Mycological Response by Disease Category Other emerging fungi · Success	2 Participants
Percentage of Participants With a Mycological Response by Disease Category Other emerging fungi · Failure	2 Participants
Percentage of Participants With a Mycological Response by Disease Category Other emerging fungi · Not Evaluable/Missing	7 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. auris) · Failure	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. albicans) · Success	3 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. albicans) · Failure	6 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. albicans) · Not Evaluable/Missing	17 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. parapsilosis) · Success	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. parapsilosis) · Failure	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. parapsilosis) · Not Evaluable/Missing	6 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. auris) · Success	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. auris) · Not Evaluable/Missing	7 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. glabrata) · Success	10 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. glabrata) · Failure	7 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. glabrata) · Not Evaluable/Missing	32 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. krusei) · Success	5 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. krusei) · Failure	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. krusei) · Not Evaluable/Missing	3 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. tropicalis) · Success	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. tropicalis) · Failure	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (C. tropicalis) · Not Evaluable/Missing	7 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (other) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (other) · Failure	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Invasive Candidiasis, including Candidemia (other) · Not Evaluable/Missing	5 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. albicans) · Success	10 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. albicans) · Failure	5 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. albicans) · Not Evaluable/Missing	32 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. glabrata) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. glabrata) · Failure	8 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. glabrata) · Not Evaluable/Missing	17 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. krusei) · Success	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. krusei) · Failure	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. krusei) · Not Evaluable/Missing	4 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. parapsilosis) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. parapsilosis) · Failure	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. parapsilosis) · Not Evaluable/Missing	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. tropicalis) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. tropicalis) · Failure	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis (C. tropicalis) · Not Evaluable/Missing	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis other) · Success	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis other) · Failure	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Mucocutaneous Candidiasis other) · Not Evaluable/Missing	5 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Dimorphic Fungi (Coccidioidomycosis) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Dimorphic Fungi (Coccidioidomycosis) · Failure	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Dimorphic Fungi (Coccidioidomycosis) · Not Evaluable/Missing	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Dimorphic Fungi (Histoplasmosis) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Dimorphic Fungi (Histoplasmosis) · Failure	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Dimorphic Fungi (Histoplasmosis) · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. nidulans) · Success	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. nidulans) · Failure	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. nidulans) · Not Evaluable/Missing	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. fumigatus) · Success	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. fumigatus) · Failure	5 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. fumigatus) · Not Evaluable/Missing	12 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. flavus) · Success	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. flavus) · Failure	1 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (A. flavus) · Not Evaluable/Missing	0 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (other) · Success	2 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (other) · Failure	7 Participants
Percentage of Participants With a Mycological Response by Disease Category and Pathogen Aspergillus Syndromes (other) · Not Evaluable/Missing	5 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Mucocutaneous Candidiasis · Failure	6 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Invasive Pulmonary Aspergillosis · Success	3 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Acute Invasive Candidiasis, including Candidemia · Success	16 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Acute Invasive Candidiasis, including Candidemia · Failure	10 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Acute Invasive Candidiasis, including Candidemia · Not Evaluable/Missing	35 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Invasive Candidiasis · Success	4 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Invasive Candidiasis · Failure	4 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Invasive Candidiasis · Not Evaluable/Missing	35 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Esophageal Candidiasis · Success	2 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Esophageal Candidiasis · Failure	5 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Esophageal Candidiasis · Not Evaluable/Missing	9 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Oropharyngeal Candidiasis · Success	7 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Oropharyngeal Candidiasis · Failure	4 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Oropharyngeal Candidiasis · Not Evaluable/Missing	3 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Mucocutaneous Candidiasis · Success	6 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Mucocutaneous Candidiasis · Not Evaluable/Missing	1 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Vulvovaginal Candidiasis · Success	11 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Vulvovaginal Candidiasis · Failure	13 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Vulvovaginal Candidiasis · Not Evaluable/Missing	8 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Disseminated/Invasive Dimorphic Fungi · Success	0 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Disseminated/Invasive Dimorphic Fungi · Failure	1 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Disseminated/Invasive Dimorphic Fungi · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Pulmonary Aspergillosis · Success	1 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Pulmonary Aspergillosis · Failure	4 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Chronic Pulmonary Aspergillosis · Not Evaluable/Missing	1 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Allergic Bronchopulmonary Aspergillosis · Success	1 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Allergic Bronchopulmonary Aspergillosis · Failure	2 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Allergic Bronchopulmonary Aspergillosis · Not Evaluable/Missing	2 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Invasive Pulmonary Aspergillosis · Failure	7 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Invasive Pulmonary Aspergillosis · Not Evaluable/Missing	19 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Other Emerging Fungi · Success	2 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Other Emerging Fungi · Failure	2 Participants
Percentage of Participants With a Mycological Response by Fungal Disease Other Emerging Fungi · Not Evaluable/Missing	7 Participants

SECONDARY outcome

Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.

The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Mycological Response by Enrollment Category Refractory · Success	21 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Refractory · Failure	33 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Refractory · Not Evaluable/Failure	74 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Resistence · Success	28 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Resistence · Failure	19 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Resistence · Not Evaluable/Failure	87 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Intolerance · Success	7 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Intolerance · Failure	10 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Intolerance · Not Evaluable/Failure	12 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Toxicities · Success	1 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Toxicities · Failure	5 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Toxicities · Not Evaluable/Failure	11 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Relapse · Success	5 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Relapse · Failure	2 Participants
Percentage of Participants With a Mycological Response by Enrollment Category Relapse · Not Evaluable/Failure	11 Participants

SECONDARY outcome

Timeframe: 42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases.

Population: Intent to Treat (ITT) population (any participant who was enrolled in the study and received at least one dose of study drug) that achieved a Global Response.

The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants With a Recurrence of Baseline Fungal Disease Esophageal Candidiasis · No Recurrence	5 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Allergic Bronchopulmonary Aspergillosis · Not Evaluable	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Other · Not Evaluable	1 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Oropharyngeal Candidiasis · Not Evaluable	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Mucotaneous Candidiasis · Recurrence	4 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Mucotaneous Candidiasis · No Recurrence	2 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Acute Invasive Candidiasis including Candidemia · Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Acute Invasive Candidiasis including Candidemia · No Recurrence	35 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Acute Invasive Candidiasis including Candidemia · Not Evaluable	5 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Invasive Candidasis · Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Invasive Candidasis · No Recurrence	29 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Invasive Candidasis · Not Evaluable	1 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Candidemia only · Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Candidemia only · No Recurrence	11 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Candidemia only · Not Evaluable	2 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Esophageal Candidiasis · Recurrence	3 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Esophageal Candidiasis · Not Evaluable	1 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Oropharyngeal Candidiasis · Recurrence	2 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Oropharyngeal Candidiasis · No Recurrence	7 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Mucotaneous Candidiasis · Not Evaluable	1 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Vulvovaginal Candidiasis · Recurrence	6 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Vulvovaginal Candidiasis · No Recurrence	18 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Vulvovaginal Candidiasis · Not Evaluable	4 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Disseminated/Invasive Dimorphic Fungi · Recurrence	1 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Disseminated/Invasive Dimorphic Fungi · No Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Disseminated/Invasive Dimorphic Fungi · Not Evaluable	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Pulmonary Aspergillosis · Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Pulmonary Aspergillosis · No Recurrence	1 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Chronic Pulmonary Aspergillosis · Not Evaluable	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Allergic Bronchopulmonary Aspergillosis · Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Allergic Bronchopulmonary Aspergillosis · No Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Invasive Pulmonary Aspergillosis · Recurrence	2 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Invasive Pulmonary Aspergillosis · No Recurrence	10 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Invasive Pulmonary Aspergillosis · Not Evaluable	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Other · Recurrence	0 Participants
Percentage of Participants With a Recurrence of Baseline Fungal Disease Other · No Recurrence	6 Participants

SECONDARY outcome

Timeframe: Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases.

Population: Intent to Treat (ITT) Population - any participant enrolled in the study who received at least one dose of study drug.

Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline.

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Percentage of Participants Surviving at Day 30 or Day 42 Candidemia · Dead	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Candidemia · Unknown	2 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Mucocutaneous Candidiasis · Unknown	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Vulvovaginal Candidiasis · Alive	32 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Pulmonary Aspergillosis · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Pulmonary Aspergillosis · Unknown	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Allergic Bronchopulmonary Aspergillosis · Alive	5 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Vulvovaginal Candidiasis · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Vulvovaginal Candidiasis · Unknown	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Disseminated/Invasive Dimorphic Fungi · Alive	3 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Disseminated/Invasive Dimorphic Fungi · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Disseminated/Invasive Dimorphic Fungi · Unknown	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Pulmonary Aspergillosis · Alive	5 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Allergic Bronchopulmonary Aspergillosis · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Allergic Bronchopulmonary Aspergillosis · Unknown	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Invasive Pulmonary Aspergillosis · Alive	22 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Invasive Pulmonary Aspergillosis · Dead	6 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Invasive Pulmonary Aspergillosis · Unknown	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Other Emerging Fungi · Alive	10 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Other Emerging Fungi · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Other Emerging Fungi · Unknown	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Acute Invasive Candidiasis · Alive	39 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Acute Invasive Candidiasis · Dead	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Acute Invasive Candidiasis · Unknown	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Invasive Candidiasis · Alive	43 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Invasive Candidiasis · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Invasive Candidiasis · Unknown	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Candidemia · Alive	17 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Esophageal Candidiasis · Alive	15 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Esophageal Candidiasis · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Esophageal Candidiasis · Unknown	1 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Oropharyngeal Candidiasis · Alive	14 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Oropharyngeal Candidiasis · Dead	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Oropharyngeal Candidiasis · Unknown	0 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Mucocutaneous Candidiasis · Alive	13 Participants
Percentage of Participants Surviving at Day 30 or Day 42 Chronic Mucocutaneous Candidiasis · Dead	0 Participants

SECONDARY outcome

Timeframe: Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.

Population: Safety Population - All subjects who received at least one dose of study drug and who had at least one safety assessment post-Baseline.

Time to death from any cause in days per Fungal Disease

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Time to Death From Any Cause Acute Invasive Candidiasis	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Candidemia	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Chronic Invasive Candidiasis	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Vulvovaginal Candidiasis	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Esophageal Candidiasis	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Oropharyngeal Candidiasis	NA Number of days Interval 122.0 to Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Chronic Mucocutaneous Candidiasis	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Diffuse/Invasive Dimorphic Fungi	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Chronic Pulmonary Aspergillosis	NA Number of days Interval 125.0 to Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Allergic Bronchopulmonary Aspergillosis	NA Number of days Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Invasive Pulmonary Aspergillosis	282 Number of days Interval 282.0 to Not Evaluable: Insufficient number of participants with events
Time to Death From Any Cause Other Emerging Fungi	270 Number of days Interval 270.0 to Not Evaluable: Insufficient number of participants with events

SECONDARY outcome

Timeframe: Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose.

Population: Pharmacokinetic (Pk) Population - all enrolled participants who provided at least one Pk sample and with no deviations significant enough to affect interpretation of the Pk data.

Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD

Outcome measures

Outcome measures
Measure	Ibrexafungerp (SCY-078) n=233 Participants Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Describe Ibrexafungerp Plasma Concentrations Day 2 post-dose	479 nanograms per milliliter (ng/mL) Interval 0.0 to 1790.0
Describe Ibrexafungerp Plasma Concentrations Day 3-5 pre-dose	644 nanograms per milliliter (ng/mL) Interval 9.21 to 1980.0
Describe Ibrexafungerp Plasma Concentrations Day 7-10 pre-dose	571 nanograms per milliliter (ng/mL) Interval 0.0 to 1810.0

Adverse Events

Ibrexafungerp (SCY-078)

Serious events: 102 serious events

Other events: 215 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Ibrexafungerp (SCY-078) n=233 participants at risk Ibrexafungerp (SCY-078), orally administered QD for up to 180 days. Ibrexafungerp: Experimental Study Drug
Infections and infestations Abdominal abscess	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Abdominal infection	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Abscess	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Acinetobacter infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Renal and urinary disorders Acute kidney injury	3.0% 7/233 • Number of events 8 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Acute left ventricular failure	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia refractory	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Acute myocardial infarction	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.3% 3/233 • Number of events 3 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Blood and lymphatic system disorders Anaemia	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Immune system disorders Anaphylactic reaction	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Arthritis bacterial	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Ascites	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Atrial fibrillation	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Atypical pneumonia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Musculoskeletal and connective tissue disorders Back pain	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Bacteraemia	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell type acute leukaemia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blastic plasmacytoid dendritic cell neoplasia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Blood and lymphatic system disorders Myelosuppression	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Bronchitis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Bronchopulmonary aspergillosis	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Bronchopulmonary aspergillosis allergic	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Candida infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Cardiac arrest	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Cardiac failure	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Cardiac failure chronic	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Cellulitis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Cerebral infarction	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.43% 1/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Psychiatric disorders Confusional state	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Coronary artery disease	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations COVID-19	2.1% 5/233 • Number of events 5 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Cystitis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Cytomegalovirus infection reactivation	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Ear and labyrinth disorders Deafness neurosensory	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Dehydration	1.7% 4/233 • Number of events 6 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Product Issues Device dislocation	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Diarrhoea	2.6% 6/233 • Number of events 7 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders Disease progression	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Disturbance in attention	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Investigations Drug clearance decreased	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Electrolyte imbalance	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Enterobacter bacteraemia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Enterobacter pneumonia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Enterococcal bacteraemia	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Escherichia bacteraemia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Escherichia infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Escherichia urinary tract infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Extradural abscess	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Facial bones fracture	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Failure to thrive	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Fall	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders Fatigue	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Blood and lymphatic system disorders Febrile neutropenia	1.3% 3/233 • Number of events 3 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Gastroenteritis viral	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Gastrointestinal anastomotic stenosis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders General physical health deterioration	0.43% 1/233 • Number of events 3 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Generalised tonic-clonic seizure	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Gout	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Haematemesis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Renal and urinary disorders Haematuria	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Haemorrhage intracranial	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Psychiatric disorders Hallucination	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations HCoV-NL63 infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Headache	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Hepatic encephalopathy	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Investigations Hepatic enzyme increased	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Surgical and medical procedures Hospitalisation	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hyperkalaemia	0.86% 2/233 • Number of events 3 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Hypocalcaemic seizure	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hypoglycaemia	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hypokalaemia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hyponatraemia	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hypophagia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Vascular disorders Hypotension	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hypovolaemia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Influenza	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Skin and subcutaneous tissue disorders Intertrigo	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Intervertebral discitis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Musculoskeletal and connective tissue disorders Joint effusion	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Kidney rupture	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Klebsiella bacteraemia	0.43% 1/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Liver abscess	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders Multiple organ dysfunction syndrome	1.3% 3/233 • Number of events 3 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Musculoskeletal and connective tissue disorders Myalgia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Mycobacterium avium complex infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Oral candidiasis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders Pain	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Pancreatic pseudocyst	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Pancreatitis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Pancreatitis acute	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Blood and lymphatic system disorders Pancytopenia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Pelvic fracture	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Pericardial effusion	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Cardiac disorders Pericarditis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pneumonia	1.7% 4/233 • Number of events 4 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pneumonia aspiration	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pneumonia bacterial	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pneumonia klebsiella	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pneumonia pseudomonal	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Procedural pneumothorax	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pseudomonal sepsis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Pseudomonas infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Psoas abscess	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Pulmonary vein stenosis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Skin and subcutaneous tissue disorders Rash	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 6/233 • Number of events 6 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Rhinovirus infection	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Sepsis	2.1% 5/233 • Number of events 5 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Septic shock	1.7% 4/233 • Number of events 4 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Vascular disorders Shock	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Skin and subcutaneous tissue disorders Skin mass	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Skin and subcutaneous tissue disorders Skin ulcer	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Small intestinal obstruction	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Somnolence	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Stenotrophomonas bacteraemia	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Streptococcal sepsis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Musculoskeletal and connective tissue disorders Synovial cyst	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Thermal burn	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Transient ischaemic attack	0.86% 2/233 • Number of events 2 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Urinary tract infection	2.1% 5/233 • Number of events 7 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Urinary tract infection pseudomonal	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Reproductive system and breast disorders Vaginal discharge	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Vascular disorders Venoocclusive disease	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Vomiting	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Reproductive system and breast disorders Vulvovaginal pruritus	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Injury, poisoning and procedural complications Weaning failure	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Wheezing	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Wound sepsis	0.43% 1/233 • Number of events 1 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.

Other adverse events

Other adverse events
Measure	Ibrexafungerp (SCY-078) n=233 participants at risk Ibrexafungerp (SCY-078), orally administered QD for up to 180 days. Ibrexafungerp: Experimental Study Drug
Gastrointestinal disorders Diarrhoea	70.0% 163/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Nausea	47.6% 111/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Vomiting	39.5% 92/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Abdominal Pain	11.2% 26/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Gastrointestinal disorders Abdominal Pain Upper	7.7% 18/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations Urinary Tract Infection	9.4% 22/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Infections and infestations COVID-19	6.0% 14/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders Pyrexia	13.3% 31/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
General disorders Fatigue	8.6% 20/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Headache	16.3% 38/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Nervous system disorders Dizziness	7.3% 17/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Decreased Appetite	5.6% 13/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Metabolism and nutrition disorders Hyperkalaemia	5.2% 12/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 13/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 12/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Skin and subcutaneous tissue disorders Rash	5.6% 13/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Renal and urinary disorders Acute Kidney Injury	6.9% 16/233 • Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.

Additional Information

Dr. David Angulo, SCYNEXIS CEO

SCYNEXIS, Inc.

Phone: 201-884-5471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place