Trial Outcomes & Findings for Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis (NCT NCT03672292)
NCT ID: NCT03672292
Last Updated: 2024-08-09
Results Overview
Number of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to a maximum of 19 weeks
Results posted on
2024-08-09
Participant Flow
Participant milestones
| Measure |
SCY-078 Plus Voriconazole
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
SCY-078 Plus Voriconazole
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
Baseline characteristics by cohort
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 14.08 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 19 weeksPopulation: Safety population including any participant treated with at least one dose of Voriconazole or SCY-078
Number of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths.
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
Number of participants with treatment emergent adverse events
|
10 participants
|
11 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
Number of participants with treatment-related adverse events
|
4 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
Number of participants discontinued due to adverse event
|
2 participants
|
4 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
Number of participants who died
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: At end of treatment (up to 13 weeks), day 42 and day 84Population: Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication.
Number and percentage of participants with Complete Response or Partial Response as determined by the Data Review Committee (DRC). Complete Response: Survival and resolution of all attributable symptoms and signs of disease; plus, successful radiological outcome; plus, mycological eradication. Partial Response: Survival and partial resolution of attributable symptoms and signs of disease; plus, improvement (at least 25%) of radiological lesions; plus, mycological eradication.
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC)
Participants with Complete or Partial Response at End of Treatment
|
7 Participants
|
9 Participants
|
|
Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC)
Participants with Complete or Partial Response at Day 42
|
4 Participants
|
6 Participants
|
|
Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC)
Participants with Complete or Partial Response at Day 84
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Day 42 and Day 84Population: Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication.
Number and Percentage of participants who died (any cause)
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Percentage of Participants Who Died (Any Cause)
Day 42
|
1 Participants
|
1 Participants
|
|
Percentage of Participants Who Died (Any Cause)
Day 84
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4 and 6Population: Participants who have a probable or proven invasive pulmonary aspergillosis at baseline, per DRC, with at least one positive serum GMI at baseline and at least one GMI value at Weeks 1, 2, 4 and/or 6.
Absolute change in serum GMI from from baseline to each time point (Weeks 1, 2, 4 and 6). Negative values indicate a reduction of GMI (i.e., improvement).
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=5 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=5 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Change in Serum Galactomannan Index (GMI)
Week 1
|
-0.1870 index
Interval -0.79 to 0.13
|
-0.4910 index
Interval -1.2 to 0.1
|
|
Change in Serum Galactomannan Index (GMI)
Week 2
|
-0.5240 index
Interval -1.68 to 0.28
|
-0.4080 index
Interval -0.87 to 0.39
|
|
Change in Serum Galactomannan Index (GMI)
Week 4
|
-0.7500 index
Interval -1.88 to 0.0
|
-0.9570 index
Interval -1.75 to -0.16
|
|
Change in Serum Galactomannan Index (GMI)
Week 6
|
-0.9950 index
Interval -1.9 to -0.03
|
-0.9570 index
Interval -1.75 to -0.16
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4 and 6 from BaselinePopulation: Modified Intent-to-treat (mITT) population including participants who have a probable or proven invasive pulmonary aspergillosis at baseline, per DRC, with at least one positive serum GMI at baseline.
Percentage of participants with the following changes in GMI values from Baseline: * Fifty percent reduction or greater at Weeks 1, 2, 4 and 6 * Twenty-five percent reduction or greater at Weeks 1, 2, 4 and 6 * Any percent reduction at Weeks 1, 2, 4 and 6 * Reduction equal to or greater than 0.25 at Weeks 1, 2, 4 and 6 * Reduction to \< 0.5 at Weeks 1, 2, 4 and 6
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=7 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=5 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Percent of Participants With Changes in GMI
Week 4 : Reduction equal to or greater than 0.25
|
3 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 6 : Twenty-five percent reduction
|
4 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 6 : Reduction to < 0.5
|
2 Participants
|
1 Participants
|
|
Percent of Participants With Changes in GMI
Week 1 : Fifty percent reduction or greater
|
0 Participants
|
1 Participants
|
|
Percent of Participants With Changes in GMI
Week 1 : Twenty-five percent reduction or greater
|
2 Participants
|
4 Participants
|
|
Percent of Participants With Changes in GMI
Week 1 : Any percent reduction
|
4 Participants
|
4 Participants
|
|
Percent of Participants With Changes in GMI
Week 1 : Reduction equal to or greater than 0.25
|
2 Participants
|
4 Participants
|
|
Percent of Participants With Changes in GMI
Week 1 : Reduction to < 0.5
|
3 Participants
|
2 Participants
|
|
Percent of Participants With Changes in GMI
Week 2 : Fifty percent reduction or greater
|
2 Participants
|
2 Participants
|
|
Percent of Participants With Changes in GMI
Week 2 : Twenty-five percent reduction
|
3 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 2 : Any percent reduction
|
4 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 2 : Reduction equal to or greater than 0.25
|
3 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 2 : Reduction to < 0.5
|
2 Participants
|
1 Participants
|
|
Percent of Participants With Changes in GMI
Week 4 : Fifty percent reduction or greater
|
3 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 4 : Twenty-five percent reduction
|
3 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 4 : Any percent reduction
|
5 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 4 : Reduction to < 0.5
|
3 Participants
|
0 Participants
|
|
Percent of Participants With Changes in GMI
Week 6 : Fifty percent reduction or greater
|
3 Participants
|
3 Participants
|
|
Percent of Participants With Changes in GMI
Week 6 : Any percent reduction
|
4 Participants
|
4 Participants
|
|
Percent of Participants With Changes in GMI
Week 6 : Reduction equal to or greater than 0.25
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 19 weeksPopulation: Intent-to-treat (ITT) population including participants who have a probable or proven invasive pulmonary aspergillosis at baseline, per DRC.
Time (days) to achieve the following changes in serum GMI from Baseline: * Fifty percent reduction * Twenty-five percent reduction * Any percent reduction * Reduction equal to or greater than 0.25
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Time to Achieve Serum GMI Change From Baseline
Fifty percent reduction
|
28.00 Days
Interval 3.0 to
Insufficient number of participants with events
|
29.00 Days
Interval 2.0 to
Insufficient number of participants with events
|
|
Time to Achieve Serum GMI Change From Baseline
Twenty-five percent reduction
|
14.00 Days
Interval 3.0 to
Insufficient number of participants with events
|
5.50 Days
Interval 2.0 to
Insufficient number of participants with events
|
|
Time to Achieve Serum GMI Change From Baseline
Any percent reduction
|
5.00 Days
Interval 3.0 to 9.0
|
3.50 Days
Interval 2.0 to 41.0
|
|
Time to Achieve Serum GMI Change From Baseline
Reduction equal to or greater than 0.25
|
NA Days
Interval 3.0 to
Insufficient number of participants with events
|
NA Days
Interval 2.0 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: End of Treatment (EoT), Day 42 and Day 84Population: Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication.
Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the DRC * Mycological Response at EoT, Day 42 and Day 84, as determined by the DRC * Radiological Response at EoT, Day 42 and Day 84, as determined by the DRC
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Clinical Response at EoT
|
6 Participants
|
9 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Clinical Response at Day 42
|
4 Participants
|
7 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Clinical Response at Day 84
|
3 Participants
|
4 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Mycological Response at EoT
|
7 Participants
|
9 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Mycological Response at Day 42
|
6 Participants
|
7 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Mycological Response at Day 84
|
4 Participants
|
4 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Radiological Response at EoT
|
7 Participants
|
9 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Radiological Response at Day 42
|
5 Participants
|
7 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
Radiological Response at Day 84
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: End of Treatment (EoT), Day 42 and Day 84Population: Intent-to-Treat (ITT) Population including all randomized participants who received at least one dose of randomized study medication.
Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Mycological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Radiological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=10 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=12 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Clinical Response at Day 84
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Radiological Response at Day 42
|
5 Participants
|
8 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Clinical Response at EoT
|
8 Participants
|
10 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Clinical Response at Day 42
|
6 Participants
|
9 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Mycological Response at EoT
|
7 Participants
|
11 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Mycological Response at Day 42
|
6 Participants
|
8 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Mycological Response at Day 84
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Radiological Response at EoT
|
7 Participants
|
10 Participants
|
|
Percentage of Participants With a Clinical, Mycological and Radiological Response.
Radiological Response at Day 84
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment Days 7 and 14 (2-4 hrs post dose)Population: Participants of study who provide a PK sample
Voriconazole and SCY-078 plasma concentrations (ng/mL)
Outcome measures
| Measure |
SCY-078 Plus Voriconazole
n=9 Participants
Either intravenous (IV) voriconazole (loading dose of 6 milligram/kilogram (mg/kg) twice a day (BID) on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards) maximum up to 13 weeks.
|
Voriconazole Mono-therapy
n=9 Participants
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards) PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given once a day (QD) from Day 3 onwards) maximum up to 13 weeks.
|
|---|---|---|
|
SCY-078 and Voriconazole Plasma Concentrations
Day 7 SCY-078 Concentration
|
1432.30 nanograms per milliliter (ng/mL)
Standard Deviation 455.59
|
—
|
|
SCY-078 and Voriconazole Plasma Concentrations
Day 14 SCY-078 Concentration
|
1312.03 nanograms per milliliter (ng/mL)
Standard Deviation 422.53
|
—
|
|
SCY-078 and Voriconazole Plasma Concentrations
Day 7 Voriconazole Concentration
|
2609.73 nanograms per milliliter (ng/mL)
Standard Deviation 2060.43
|
2891.72 nanograms per milliliter (ng/mL)
Standard Deviation 1557.20
|
|
SCY-078 and Voriconazole Plasma Concentrations
Day 14 Voriconazole Concentration
|
2074.24 nanograms per milliliter (ng/mL)
Standard Deviation 1201.28
|
2963.49 nanograms per milliliter (ng/mL)
Standard Deviation 1583.51
|
Adverse Events
SCY-078 Plus Voriconazole
Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths
Voriconazole Mono-therapy
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SCY-078 Plus Voriconazole
n=10 participants at risk
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).
PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks
SCY-078: Oral tablets of SCY-078
Voriconazole: Voriconazole IV vials or oral tablets
|
Voriconazole Mono-therapy
n=12 participants at risk
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).
PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards).
Treatment duration = minimum 6 weeks/Max 13 weeks
Voriconazole: Voriconazole IV vials or oral tablets
Oral Placebo Tablets: Oral Placebo Tablets matching SCY-078
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Disease progression
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Heart transplant rejection
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Enterococcal sepsis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Disturbance in attention
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
Other adverse events
| Measure |
SCY-078 Plus Voriconazole
n=10 participants at risk
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).
PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks
SCY-078: Oral tablets of SCY-078
Voriconazole: Voriconazole IV vials or oral tablets
|
Voriconazole Mono-therapy
n=12 participants at risk
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).
PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards).
Treatment duration = minimum 6 weeks/Max 13 weeks
Voriconazole: Voriconazole IV vials or oral tablets
Oral Placebo Tablets: Oral Placebo Tablets matching SCY-078
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Haemolysis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Eye disorders
Eye haematoma
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Eye disorders
Eye haemorrhage
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Eye disorders
Photopsia
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Oral blood blister
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Terminal ileitis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Toothache
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Vomiting
|
30.0%
3/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Chest pain
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Disease progression
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Pain
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Acute graft versus host disease in liver
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Graft versus host disease in liver
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Graft versus host disease in skin
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Immune system disorders
Heart transplant rejection
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Blastocystis infection
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Enterococcal bacteraemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Enterococcal infection
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Enterococcal sepsis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
25.0%
3/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Staphylococcal infection
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Streptococcal sepsis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Infections and infestations
Urosepsis
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Drug level decreased
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Ejection fraction decreased
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Fluid retention
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
25.0%
3/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Anosmia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Disturbance in attention
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Psychiatric disorders
Confusional state
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Renal and urinary disorders
Urethral pain
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
16.7%
2/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
25.0%
3/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Through study completion, an average of 19 weeks
|
0.00%
0/12 • Through study completion, an average of 19 weeks
|
|
Investigations
Blood cholesterol
|
0.00%
0/10 • Through study completion, an average of 19 weeks
|
8.3%
1/12 • Through study completion, an average of 19 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place