A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants

An AE is any untoward medical occurrence in a participant administered a study drug, which does not have to have a causal relationship with this treatment. It can be any unfavorable sign, symptom, or disease temporally associated with the use of a medicinal product.

TEAE is defined as an AE observed after starting administration of the study drug through 30 days after the last dose.

All - Cause Mortality Through Day 42

EOT was defined as anytime from "day 1 to a maximum of day 180". Data reported in the table below for each category, i.e., Day 84 represented data between Day 1 and Day 84 and for EOT, data represented between Day 1 to the EOT day for each individual. Participants who died after EOT assessment but before reaching Day 84 were included in the data for Day 84 category. Only those deaths that occurred after Day 84 would be included in EOT category if the death occurred during the treatment period (i.e. prior to the EOT).

Overall response was based on a composite of clinical, mycological, and radiological responses with success criteria assessed. Success criteria as assessed by AC in:

Clinical response:

• Complete: Resolution of all attributable clinical symptoms and physical findings
• Partial: Resolution of at Least some of the clinical symptoms and physical findings associated with IFD

Mycological response:

• Eradication: No growth of the original (at baseline) causative organism on culture or identified by histology/cytology on post baseline (after day 7) cultures and/or histology/cytology
• Presumed eradication: Missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding

Radiological response:

• Complete: ≥ 90% improvement
• Partial: At least < 25% response at day 42 and at least 50% by Day 84

AC Assessed Clinical response was defined as follows:

• Success: Complete (if resolution of all attributable clinical symptoms and physical findings occurs); Partial (if resolution of at least some of the clinical symptoms and physical findings associated with IFD)
• Failure: Stable (if minor of no change in clinical symptoms and physical findings associated with IFD); Progression (if worsening or new clinical symptoms and physical findings associated with IFD, or if alternative systemic antifungal treatment is required)
• Not Evaluable: If not assessed or no clinical signs or symptoms at baseline
• No assessment: Those participants that do not fall under any of the above criteria

Investigator-assessed Clinical Response was defined as follows:

• Success: if resolution of all attributable signs and symptoms or resolution of attributable clinical symptoms and physical findings
• Failure: if no resolution of any attributable signs and symptoms or no resolution of any attributable signs and symptoms (no change) or worsening of any attributable signs and symptoms
• Not Evaluable: if results not available /participant unevaluable or if no attributable signs and symptoms
• No assessment: Those participants that do not fall under any of the above criteria

AC-assessed Radiological Response was defined as follows:

• Success: Complete (if ≥ 90% improvement); Partial (if at least < 25% response at day 42 and at least 50% response by Day 84)
• Failure: Stable (if minor or no change in radiographic abnormalities associated with IFD, but no signs of progression); Progression (if worsening or new radiological abnormalities associated with IRD)
• Not Evaluable: if no post baseline radiology available with baseline evidence of radiolical disease Or Radiology not applicable at baseline
• No assessment: Those participants that do not fall under any of the above criteria

Investigator's assessed radiological response was defined as follows:

• Success: if ≥ 90% improvement, ≥ 50% to < 90% improvement, ≥ 25% to 50% improvement (for Day 42 only)
• Failure if < 25% improvement at any time or no signs or radiological Images
• Not Evaluable if results not evaluable or no radiological data available
• No assessment: Those participants that do not fall under any of the above criteria

AC assessed mycological response was defined as follows:

• Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)
• Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)
• Not Evaluable - no mycological evidence
• No assessment: Those participants that do not fall under any of the above criteria

Investigator's assessed mycological response was defined as follows:

• Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)
• Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)
• Not Evaluable: Indeterminate/no mycological follow-up or results available
• No assessment: Those participants that do not fall under any of the above criteria

Ctrough was defined as the predose concentration at the end of dosing interval.