Trial Outcomes & Findings for Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi (NCT NCT05630976)
NCT ID: NCT05630976
Last Updated: 2026-05-27
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Results posted on
2026-05-27
Participant Flow
A total of 70 participants with invasive fungal disease (IFD) were enrolled and treated in the study.
Participant milestones
| Measure |
Isavuconazole
Participants were administered loading dose of isavuconazole as 200 milligram (mg) injection intravenously (IV) every 8 hours for 6 doses or as 200 mg capsules orally (PO) every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with invasive aspergillosis \[IA\] or other filamentous fungi infection or up to 180 days for participants with invasive mucormycosis \[IM\]).
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Isavuconazole
Participants were administered loading dose of isavuconazole as 200 milligram (mg) injection intravenously (IV) every 8 hours for 6 doses or as 200 mg capsules orally (PO) every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with invasive aspergillosis \[IA\] or other filamentous fungi infection or up to 180 days for participants with invasive mucormycosis \[IM\]).
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|---|---|
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Overall Study
Death
|
13
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
Baseline characteristics by cohort
| Measure |
Isavuconazole
n=70 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection or up to 180 days for participants with IM).
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|---|---|
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Age, Continuous
|
60 Years
STANDARD_DEVIATION 14.02 • n=51 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
9 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: After first dose of study intervention (Day 1) through Day 42Population: Intention to treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study intervention.
All-cause mortality included any death that occurred after first dose of study drug through Day 42 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 42 and b) unknown deaths: unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 42. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths \[actual\] and unknown deaths \[not actual but treated as deaths\]) among the overall number of participants analyzed.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=70 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
|
All-cause Mortality Rate Through Day 42
|
—
|
14.3 Percentage of participants
Interval 7.069 to 24.707
|
SECONDARY outcome
Timeframe: After first dose of study intervention (Day 1) through Day 84Population: ITT population consisted of all enrolled participants who received at least 1 dose of study intervention.
All-cause mortality included any death that occurred after first dose of study drug through Day 84 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 84 and b) unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 84. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths \[actual\] and unknown deaths \[not actual but treated as deaths\]) among the overall number of participants analyzed.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=70 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
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All-cause Mortality Rate Through Day 84
|
—
|
28.6 Percentage of participants
Interval 18.405 to 40.622
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before or at Day 180)Population: mITT population consisted of all enrolled participants who received at least 1 dose of study intervention and who had proven, or probable IFD as determined by investigators.
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for:a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings;b)A success radiological response means:1) greater than equal to(\>=) 90 percent (%)improvement from screening,2)\>= 50% to less than(\<)90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)\>=25% to \<50% improvement from screening (For Day 42 and EOT (that is before Day 180) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c)mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=51 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
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Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
Day 42
|
—
|
62.7 Percentage of participants
Interval 48.08 to 75.874
|
|
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
Day 84
|
—
|
56.9 Percentage of participants
Interval 42.245 to 70.655
|
|
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
EOT
|
—
|
60.8 Percentage of participants
Interval 46.114 to 74.156
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before or at Day 84)Population: myITT-IA population consisted of all enrolled participants who received at least 1 dose of study intervention and who had proven, or probable IA based on cytology, histology, culture, or galactomannan (GM) and as assessed by the investigators.
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for: a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings; b)A success radiological response means:1) \>= 90 percent (%)improvement from screening, 2)\>= 50% to \< 90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)\>=25% to \<50% improvement from screening (For Day 42 and EOT (that is before Day 84) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c) mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=42 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
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Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
Day 42
|
—
|
61.9 Percentage of participants
Interval 45.637 to 76.428
|
|
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
Day 84
|
—
|
57.1 Percentage of participants
Interval 40.961 to 72.279
|
|
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
EOT
|
—
|
61.9 Percentage of participants
Interval 45.637 to 76.428
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before or at Day 180)Population: mITT population consisted of ITT participants who had proven, or probable IFD as determined by investigators. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for each row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=51 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
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Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
EOT
|
—
|
69.4 Percentage of participants
Interval 54.585 to 81.748
|
|
Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
Day 42
|
—
|
73.5 Percentage of participants
Interval 58.918 to 85.053
|
|
Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
Day 84
|
—
|
66 Percentage of participants
Interval 51.235 to 78.795
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before or at Day 84)Population: myITT-IA analysis set consisted of mITT participants with proven or probable IA based on cytology, histology, culture, or GM and assessed by the investigators. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for each row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success among all evaluable participants (excluding assessment not applicable participants) at specified time points. Clinical success rate: percentage of participants with clinical success at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=42 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
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|---|---|---|
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Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Day 42
|
—
|
72.5 Percentage of participants
Interval 56.112 to 85.399
|
|
Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Day 84
|
—
|
65.9 Percentage of participants
Interval 49.405 to 79.917
|
|
Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
EOT
|
—
|
72.5 Percentage of participants
Interval 56.112 to 85.399
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before or at Day 180)Population: mITT population consisted of ITT participants who had proven, or probable IFD as determined by investigators. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=51 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
Day 84
|
—
|
64.7 Percentage of participants
Interval 50.068 to 77.569
|
|
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
Day 42
|
—
|
72 Percentage of participants
Interval 57.509 to 83.769
|
|
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
EOT
|
—
|
68 Percentage of participants
Interval 53.301 to 80.48
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before or at Day 84)Population: myITT-IA population consisted of mITT participants with proven or probable IA based on cytology, histology, culture, or GM and assessed by the investigators. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=42 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Day 42
|
—
|
70.7 Percentage of participants
Interval 54.463 to 83.87
|
|
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Day 84
|
—
|
64.3 Percentage of participants
Interval 48.026 to 78.449
|
|
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
EOT
|
—
|
70.7 Percentage of participants
Interval 54.463 to 83.87
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day or at before Day 180)Population: mITT population consisted of ITT participants who had proven, or probable IFD as determined by investigators. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for each row.
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) \>=90% improvement from screening, (2) \>=50% to \<90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) \>=25% to \<50% improvement from screening for Day 42 and EOT (that is before Day 180). Success rate: percentage of participants with successful radiological response at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=51 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
Day 42
|
—
|
66 Percentage of participants
Interval 51.235 to 78.795
|
|
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
Day 84
|
—
|
60 Percentage of participants
Interval 45.179 to 73.592
|
|
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
EOT
|
—
|
64 Percentage of participants
Interval 49.193 to 77.084
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and EOT (any day before Day 84)Population: myITT-IA population consisted of mITT participants with proven or probable IA based on cytology, histology, culture, or GM and assessed by the investigators.
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) \>=90% improvement from screening, (2) \>=50% to \<90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) \>=25% to \<50% improvement from screening for Day 42 and EOT (that is before Day 84). Success rate: percentage of participants with successful radiological response at specified time points.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=42 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Day 42
|
—
|
66.7 Percentage of participants
Interval 50.451 to 80.433
|
|
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Day 84
|
—
|
61.9 Percentage of participants
Interval 45.637 to 76.428
|
|
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
EOT
|
—
|
66.7 Percentage of participants
Interval 50.451 to 80.433
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. Treatment related TEAEs were TEAEs related to study intervention. AEs included both serious and all non-SAEs.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Treatment Related TEAEs
|
9 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, is life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was a congenital anomaly/birth defect. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
|
3 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. In this outcome measure, number of participants with TEAEs leading to study intervention discontinuation (during study treatment) were reported.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Study Intervention Discontinuation
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. In this outcome measure, number of participants with TEAEs leading to death (during study treatment) were reported.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With TEAEs Leading to Death
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
Number of participants with death due to any cause were reported in this outcome measure.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Death
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Clinical laboratory abnormalities test criteria included, a) hematology: hemoglobin with primary criteria of \<0.8\* lower limit of normal (LLN), erythrocytes \<0.8\* LLN, platelets \<0.5\* LLN \>1.75\* upper limit of normal (ULN), leukocytes \< 0.6\* LLN and \> 1.5\* ULN, lymphocytes and neutrophils \< 0.8\* LLN and \> 1.2\* ULN. b) Chemistry: bilirubin and direct bilirubin \>1.5\* ULN, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase \>3.0\* ULN, urea nitrogen, urea and creatinine \>1.3\* ULN, sodium \<0.95\* LLN and potassium\<0.9\* LLN. c) urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin and bilirubin, urobilinogen, nitrite leukocyte esterase \>= 1. Number of participants with any laboratory abnormalities were reported in this outcome measure.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=60 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
8 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
Vital signs included systolic and diastolic blood pressures and pulse rate. Clinical significance of vital signs was judged by the investigator.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Predefined ECG criteria of clinical significance: a) heart rate (beats per minute \[bpm\]): value \<40 and value \>120; b) PR interval (millisecond \[(msec)\]: value\>280; c) QRS interval (msec): value\>120 d) QTc corrected using Fridericia's formula (QTcF) (msec): value \>500 and new prolongation value \>480 or increase \>= 60. Only those pre-defined ECG categories for which non-zero data were available have been reported below.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
Heart rate: value>120 beats/min
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
QRS interval: value>120 msec
|
0 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
QTCF: value>480 or Increase >= 60 msec
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)Population: Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
The eye examination included visual acuity, confrontational visual field testing and color perception testing. Any abnormality was assessed by a qualified ophthalmologist.
Outcome measures
| Measure |
Invasive Mucormycosis
n=9 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=61 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Number of Participants With Abnormal Eye Examination
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)Population: Pharmacokinetic (PK) concentration analysis set included all participants who were treated and had at least 1 measurable PK concentration data, and who had no major protocol violations that had an effect on their PK data. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for each row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.
Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
Outcome measures
| Measure |
Invasive Mucormycosis
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
Invasive Aspergillosis + Other
n=69 Participants
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
|---|---|---|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 14: 6 hours post -dose
|
—
|
6498 Nanogram per milliliter (ng/mL)
Standard Deviation 2522.5
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 14: 12 hours post -dose
|
—
|
5946 Nanogram per milliliter (ng/mL)
Standard Deviation 1964.6
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
EOT: 0 hours
|
—
|
7224 Nanogram per milliliter (ng/mL)
Standard Deviation 3665.2
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
EOT: 24 hours (post -dose)
|
—
|
6671 Nanogram per milliliter (ng/mL)
Standard Deviation 2802.9
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 14: 24 hours post -dose
|
—
|
5448 Nanogram per milliliter (ng/mL)
Standard Deviation 1917.6
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 3: 0 hour
|
—
|
3920 Nanogram per milliliter (ng/mL)
Standard Deviation 1658.7
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 3: 1.5 hours post -dose
|
—
|
5076 Nanogram per milliliter (ng/mL)
Standard Deviation 2476.7
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 7: 0 hour
|
—
|
4715 Nanogram per milliliter (ng/mL)
Standard Deviation 1773.2
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 7: 1.5 hours post -dose
|
—
|
5394 Nanogram per milliliter (ng/mL)
Standard Deviation 1968.9
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 7: 3 hours post -dose
|
—
|
5824 Nanogram per milliliter (ng/mL)
Standard Deviation 1891.2
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 7: 6 hours post -dose
|
—
|
5357 Nanogram per milliliter (ng/mL)
Standard Deviation 1934.9
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 7: 12 hours post -dose
|
—
|
4988 Nanogram per milliliter (ng/mL)
Standard Deviation 1936.5
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 7: 24 hours post -dose
|
—
|
4938 Nanogram per milliliter (ng/mL)
Standard Deviation 2158.7
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 14: 0 hour
|
—
|
5957 Nanogram per milliliter (ng/mL)
Standard Deviation 2003.3
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 14: 1.5 hours post -dose
|
—
|
6543 Nanogram per milliliter (ng/mL)
Standard Deviation 2081.5
|
|
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Day 14: 3 hours post -dose
|
—
|
7281 Nanogram per milliliter (ng/mL)
Standard Deviation 2179.9
|
Adverse Events
Invasive Aspergillosis + Other
Serious events: 19 serious events
Other events: 50 other events
Deaths: 11 deaths
Invasive Mucormycosis
Serious events: 3 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Invasive Aspergillosis + Other
n=61 participants at risk
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
Invasive Mucormycosis
n=9 participants at risk
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
|---|---|---|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Cardiogenic shock
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Pneumonia
|
4.9%
3/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Tuberculosis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
Other adverse events
| Measure |
Invasive Aspergillosis + Other
n=61 participants at risk
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 84 days for participants with IA or other filamentous fungi infection).
|
Invasive Mucormycosis
n=9 participants at risk
Participants were administered loading dose of isavuconazole as 200 mg injection IV every 8 hours for 6 doses or as 200 mg capsules PO every 8 hours for 6 doses for first 48 hours followed by maintenance doses of 200 mg injection single IV dose once daily or 200 mg capsule PO once daily from Day 3 up to end of treatment (maximum up to 180 days for participants with IM).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.7%
12/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
44.4%
4/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.8%
6/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Bundle branch block right
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Defect conduction intraventricular
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Sinus tachycardia
|
4.9%
3/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
9.8%
6/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Eye disorders
Cataract
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Eye disorders
Dry eye
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Eye disorders
Visual impairment
|
4.9%
3/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Gastrointestinal disorders
Constipation
|
8.2%
5/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
5/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Gastrointestinal disorders
Nausea
|
9.8%
6/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
5/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
General disorders
Chest pain
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
General disorders
Pyrexia
|
16.4%
10/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
33.3%
3/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
33.3%
3/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Conjunctivitis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Infections and infestations
Pneumonia
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Alanine aminotransferase increased
|
13.1%
8/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Blood cholinesterase abnormal
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Electrocardiogram ST-T change
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Electrocardiogram T wave abnormal
|
8.2%
5/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Electrocardiogram high voltage
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.4%
10/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
33.3%
3/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Neutrophil count decreased
|
4.9%
3/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Platelet count increased
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Protein urine present
|
4.9%
3/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
Urinary occult blood positive
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Investigations
White blood cell count decreased
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.2%
5/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
13.1%
8/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.8%
9/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.3%
13/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
55.6%
5/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.8%
9/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
13.1%
8/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
44.4%
4/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Nervous system disorders
Dizziness
|
6.6%
4/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Leukocyturia
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Proteinuria
|
8.2%
5/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
0.00%
0/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
2/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Suffocation feeling
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
11.1%
1/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
|
Vascular disorders
Phlebitis
|
1.6%
1/61 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
22.2%
2/9 • From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Same event may appear as AE and SAE, but what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious and non-SAE. Safety population consisted of all enrolled participants who received at least 1 dose of study intervention. Number of deaths reported in AE section under "All-Cause Mortality" were the actual number of deaths that occurred till end of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER