Trial Outcomes & Findings for A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (NCT NCT05178862)
NCT ID: NCT05178862
Last Updated: 2026-08-10
Results Overview
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
Day 30
Results posted on
2026-08-10
Participant Flow
Participant milestones
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin.
Participants who were assigned to Oral ibrexafungerp but had a fluconazole resistant pathogen received unblinded ibrexafungerp.
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a fluconazole resistant pathogen received unblinded Best Available Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
32
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measurements were not performed for all participants at Baseline.
Baseline characteristics by cohort
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
n=36 Participants
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
n=32 Participants
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a fluconazole resistant pathogen received Best Available Therapy
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Weight
|
82.57 kilograms
STANDARD_DEVIATION 25.563 • n=31 Participants • Measurements were not performed for all participants at Baseline.
|
71.23 kilograms
STANDARD_DEVIATION 22.331 • n=27 Participants • Measurements were not performed for all participants at Baseline.
|
77.29 kilograms
STANDARD_DEVIATION 24.575 • n=58 Participants • Measurements were not performed for all participants at Baseline.
|
|
Body Mass Index (BMI)
|
28.5 kilograms per meter squared
STANDARD_DEVIATION 7.903 • n=31 Participants • Measurements were not performed for all participants at Baseline.
|
26.54 kilograms per meter squared
STANDARD_DEVIATION 12.280 • n=27 Participants • Measurements were not performed for all participants at Baseline.
|
27.59 kilograms per meter squared
STANDARD_DEVIATION 10.13 • n=58 Participants • Measurements were not performed for all participants at Baseline.
|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 16.5 • n=36 Participants
|
60 years
STANDARD_DEVIATION 14.65 • n=32 Participants
|
57.6 years
STANDARD_DEVIATION 15.71 • n=68 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=36 Participants
|
15 Participants
n=32 Participants
|
37 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=36 Participants
|
17 Participants
n=32 Participants
|
31 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=36 Participants
|
2 Participants
n=32 Participants
|
7 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
10 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=36 Participants
|
22 Participants
n=32 Participants
|
47 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
4 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=36 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=36 Participants
|
26 Participants
n=32 Participants
|
61 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
4 Participants
n=68 Participants
|
|
Height
|
169.59 centimeters
STANDARD_DEVIATION 9.508 • n=31 Participants • Measurements were not performed for all participants at Baseline.
|
166.20 centimeters
STANDARD_DEVIATION 11.933 • n=27 Participants • Measurements were not performed for all participants at Baseline.
|
168.02 centimeters
STANDARD_DEVIATION 10.744 • n=58 Participants • Measurements were not performed for all participants at Baseline.
|
|
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score
</= 20
|
31 Participants
n=36 Participants
|
31 Participants
n=32 Participants
|
62 Participants
n=68 Participants
|
|
Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score
>20
|
5 Participants
n=36 Participants
|
1 Participants
n=32 Participants
|
6 Participants
n=68 Participants
|
|
Absolute Neutrophil Count
</= 500 per cubic millimeter
|
2 Participants
n=36 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=68 Participants
|
|
Absolute Neutrophil Count
> 500 per cubic millimeter
|
34 Participants
n=36 Participants
|
30 Participants
n=32 Participants
|
64 Participants
n=68 Participants
|
|
Risk factors for mortality
Acute Kidney Injury
|
9 Participants
n=36 Participants
|
8 Participants
n=32 Participants
|
17 Participants
n=68 Participants
|
|
Risk factors for mortality
Broad Spectrum Antibiotics
|
22 Participants
n=36 Participants
|
9 Participants
n=32 Participants
|
31 Participants
n=68 Participants
|
|
Risk factors for mortality
Burns
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Risk factors for mortality
Central Venous Catheter not removed
|
8 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
12 Participants
n=68 Participants
|
|
Risk factors for mortality
Diabetes mellitus
|
10 Participants
n=36 Participants
|
9 Participants
n=32 Participants
|
19 Participants
n=68 Participants
|
|
Risk factors for mortality
Dialysis
|
4 Participants
n=36 Participants
|
6 Participants
n=32 Participants
|
10 Participants
n=68 Participants
|
|
Risk factors for mortality
End stage renal disease
|
2 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=68 Participants
|
|
Risk factors for mortality
Gastrointestinal perforation
|
2 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=68 Participants
|
|
Risk factors for mortality
Hepatic Dysfunction
|
5 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
5 Participants
n=68 Participants
|
|
Risk factors for mortality
ICU admission
|
12 Participants
n=36 Participants
|
9 Participants
n=32 Participants
|
21 Participants
n=68 Participants
|
|
Risk factors for mortality
Immunosuppressive therapy
|
9 Participants
n=36 Participants
|
12 Participants
n=32 Participants
|
21 Participants
n=68 Participants
|
|
Risk factors for mortality
Major surgery
|
10 Participants
n=36 Participants
|
8 Participants
n=32 Participants
|
18 Participants
n=68 Participants
|
|
Risk factors for mortality
Mechanical Ventilation
|
5 Participants
n=36 Participants
|
2 Participants
n=32 Participants
|
7 Participants
n=68 Participants
|
|
Risk factors for mortality
Neutropenia (ANC </= 1500 cells per cu mm)
|
1 Participants
n=36 Participants
|
3 Participants
n=32 Participants
|
4 Participants
n=68 Participants
|
|
Risk factors for mortality
Pancreatitis
|
2 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=68 Participants
|
|
Risk factors for mortality
Presence of septic shock
|
6 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
10 Participants
n=68 Participants
|
|
Risk factors for mortality
Source control within 24 Hours
|
2 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=68 Participants
|
|
Risk factors for mortality
Thrombocytopenia (platelets<150,000/uL)
|
4 Participants
n=36 Participants
|
3 Participants
n=32 Participants
|
7 Participants
n=68 Participants
|
|
Risk factors for mortality
Total Parenteral Nutrition
|
6 Participants
n=36 Participants
|
8 Participants
n=32 Participants
|
14 Participants
n=68 Participants
|
|
Risk factors for mortality
Other
|
9 Participants
n=36 Participants
|
3 Participants
n=32 Participants
|
12 Participants
n=68 Participants
|
|
Retinal examination at Baseline
Abnormal, due to Candida Infection
|
0 Participants
n=29 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
0 Participants
n=28 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
0 Participants
n=57 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
|
Retinal examination at Baseline
Abnormal, not due to Candida Infection
|
8 Participants
n=29 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
5 Participants
n=28 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
13 Participants
n=57 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
|
Retinal examination at Baseline
Normal
|
19 Participants
n=29 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
21 Participants
n=28 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
40 Participants
n=57 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
|
Retinal examination at Baseline
Not Done
|
2 Participants
n=29 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
2 Participants
n=28 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
4 Participants
n=57 Participants • Retinal Examination only required in participants with Candidemia (N=29). Denominator is the number of patients with candidemia at diagnosis.
|
|
Left Ventricular Ejection Fraction at Baseline
|
60.0 % of ejected blood from left ventricle
STANDARD_DEVIATION 8.84 • n=24 Participants • Echocardiography results, if performed per standard of care were collected if applicable.
|
54.0 % of ejected blood from left ventricle
STANDARD_DEVIATION 11.23 • n=14 Participants • Echocardiography results, if performed per standard of care were collected if applicable.
|
57.8 % of ejected blood from left ventricle
STANDARD_DEVIATION 10.08 • n=38 Participants • Echocardiography results, if performed per standard of care were collected if applicable.
|
|
Echocardiography/MUGA at Baseline
Normal
|
13 Participants
n=36 Participants
|
6 Participants
n=32 Participants
|
19 Participants
n=68 Participants
|
|
Echocardiography/MUGA at Baseline
Abnormal - Not Clinically Significant
|
10 Participants
n=36 Participants
|
8 Participants
n=32 Participants
|
18 Participants
n=68 Participants
|
|
Echocardiography/MUGA at Baseline
Abnormal - Clinically Significant
|
1 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=68 Participants
|
|
Echocardiography/MUGA at Baseline
Not Evaluable
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Echocardiography/MUGA at Baseline
Not Done
|
12 Participants
n=36 Participants
|
18 Participants
n=32 Participants
|
30 Participants
n=68 Participants
|
|
Electrocardiogram Interpretation at Baseline
Normal
|
15 Participants
n=36 Participants
|
12 Participants
n=32 Participants
|
27 Participants
n=68 Participants
|
|
Electrocardiogram Interpretation at Baseline
Abnormal - Not Clinically Significant
|
13 Participants
n=36 Participants
|
14 Participants
n=32 Participants
|
27 Participants
n=68 Participants
|
|
Electrocardiogram Interpretation at Baseline
Abnormal - Clinically Significant
|
2 Participants
n=36 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=68 Participants
|
|
Electrocardiogram Interpretation at Baseline
Not Evaluable
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Electrocardiogram Interpretation at Baseline
Not Done
|
6 Participants
n=36 Participants
|
4 Participants
n=32 Participants
|
10 Participants
n=68 Participants
|
|
Electrocardiogram PR Interval at Baseline
|
151.0 milliseconds
STANDARD_DEVIATION 28.22 • n=29 Participants • Measurements were not performed for all participants at Baseline.
|
146.7 milliseconds
STANDARD_DEVIATION 25.90 • n=27 Participants • Measurements were not performed for all participants at Baseline.
|
148.9 milliseconds
STANDARD_DEVIATION 26.97 • n=56 Participants • Measurements were not performed for all participants at Baseline.
|
|
Electrocardiogram RR Interval at Baseline
|
692.8 milliseconds
STANDARD_DEVIATION 164.54 • n=28 Participants • Measurements were not performed for all participants at Baseline.
|
746.3 milliseconds
STANDARD_DEVIATION 192.13 • n=25 Participants • Measurements were not performed for all participants at Baseline.
|
718.0 milliseconds
STANDARD_DEVIATION 178.39 • n=53 Participants • Measurements were not performed for all participants at Baseline.
|
|
Electrocardiogram QRS Interval at Baseline
|
89.0 milliseconds
STANDARD_DEVIATION 17.79 • n=30 Participants • Measurements were not performed for all participants at Baseline.
|
92.3 milliseconds
STANDARD_DEVIATION 25.01 • n=28 Participants • Measurements were not performed for all participants at Baseline.
|
90.6 milliseconds
STANDARD_DEVIATION 21.45 • n=58 Participants • Measurements were not performed for all participants at Baseline.
|
|
Electrocardiogram QT Interval at Baseline
|
367.8 milliseconds
STANDARD_DEVIATION 40.57 • n=30 Participants • Measurements were not performed for all participants at Baseline.
|
384.6 milliseconds
STANDARD_DEVIATION 45.04 • n=28 Participants • Measurements were not performed for all participants at Baseline.
|
375.9 milliseconds
STANDARD_DEVIATION 43.25 • n=58 Participants • Measurements were not performed for all participants at Baseline.
|
|
Electrocardiogram QTcF Interval at Baseline
|
416.2 milliseconds
STANDARD_DEVIATION 23.07 • n=30 Participants • Measurements were not performed for all participants at Baseline.
|
428.3 milliseconds
STANDARD_DEVIATION 31.15 • n=27 Participants • Measurements were not performed for all participants at Baseline.
|
421.9 milliseconds
STANDARD_DEVIATION 27.63 • n=57 Participants • Measurements were not performed for all participants at Baseline.
|
PRIMARY outcome
Timeframe: Day 30Population: 5 cases Not Known withdrew from the study prior to Day 30
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Outcome measures
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
n=36 Participants
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
n=32 Participants
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a resistant pathogen received Best Available Therapy
|
|---|---|---|
|
All-cause Mortality
Alive
|
28 Participants
|
28 Participants
|
|
All-cause Mortality
Deceased
|
4 Participants
|
3 Participants
|
|
All-cause Mortality
Not Known
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Study was terminated and data review committee was canceled. The data required to populate this table is not available due to the cancelation of the DRC. The data will not be available or reported in the future.
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Outcome measures
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a resistant pathogen received Best Available Therapy
|
|---|---|---|
|
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Study was terminated and data review committee was canceled. The data required to populate this table is not available due to the cancelation of the DRC. The data will not be available or reported in the future.
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Outcome measures
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a resistant pathogen received Best Available Therapy
|
|---|---|---|
|
Global Response at Day 14
|
0 Participants
|
0 Participants
|
Adverse Events
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
Serious events: 20 serious events
Other events: 27 other events
Deaths: 4 deaths
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
Serious events: 20 serious events
Other events: 28 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
n=36 participants at risk
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
n=32 participants at risk
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a fluconazole resistant pathogen received Best Available Therapy
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
18.8%
6/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Bacteraemia
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Bacterial sepsis
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Acinetobacter sepsis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Catheter site infection
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Endocarditis candida
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Lung abscess
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Pneumonia bacterial
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Pseudomonas infection
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Septic shock
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Staphylococcal infection
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Tubo-ovarian abscess
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Vascular device infection
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
4/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
General disorders
Pyrexia
|
5.6%
2/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
General disorders
Disease progression
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
General disorders
General physical health deterioration
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Cardiac disorders
Bradycardia
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Product Issues
Device dislocation
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
0.00%
0/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Investigations
Enterococcus test positive
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal lymphoma
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
Other adverse events
| Measure |
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)
n=36 participants at risk
SCY-078: Oral ibrexafungerp (SCY-078) as step-down therapy.
Echinocandin: Intravenous echinocandin
|
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy
n=32 participants at risk
Fluconazole: Oral fluconazole as step-down therapy.
Echinocandin: Intravenous echinocandin
Participants who were assigned to Oral fluconazole but had a fluconazole resistant pathogen received Best Available Therapy
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.9%
5/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
15.6%
5/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
6/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
9.4%
3/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
9.4%
3/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
4/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
12.5%
4/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
21.9%
7/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Infections and infestations
Pneumonia
|
11.1%
4/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
3.1%
1/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
21.9%
7/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
General disorders
Pyrexia
|
8.3%
3/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
3/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
12.5%
4/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
2/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
6.2%
2/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.9%
5/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
9.4%
3/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
|
Product Issues
Device dislocation
|
2.8%
1/36 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
9.4%
3/32 • For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.
Each treatment arm includes an IV to Oral component.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place