Trial Outcomes & Findings for Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis (NCT NCT00412893)

Last Updated: 2024-12-10

Results Overview

All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

527 participants

Primary outcome timeframe

Through Day 42

Results posted on

2024-12-10

Participant Flow

Consenting adult patients with proven, probable or possible invasive fungal disease (IFD) caused by Aspergillus species or other filamentous fungi, meeting the inclusion/exclusion criteria, were enrolled in the study.

Participants were stratified by geographic location (North America; Western Europe plus Australia and New Zealand; and Other Regions), whether or not they underwent an allogeneic bone marrow transplant (BMT) and whether or not they had uncontrolled malignancy.

Participant milestones

Participant milestones
Measure	Isavuconazole Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Overall Study STARTED	263	264
Overall Study Received Treatment	258	258
Overall Study COMPLETED	118	120
Overall Study NOT COMPLETED	145	144

Reasons for withdrawal

Reasons for withdrawal
Measure	Isavuconazole Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Overall Study Adverse Event	31	53
Overall Study Death	17	21
Overall Study Insufficient Therapeutic Response	39	23
Overall Study Lost to Follow-up	2	1
Overall Study Violation of Selection at Entry	17	10
Overall Study Other Protocol Violation	10	6
Overall Study Did Not Cooperate	12	9
Overall Study Administrative Reason	12	15
Overall Study Randomized but Never Received Study Drug	5	6

Baseline Characteristics

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Isavuconazole n=258 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=258 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.	Total n=516 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 16.15 • n=5 Participants	51.2 years STANDARD_DEVIATION 15.85 • n=7 Participants	51.1 years STANDARD_DEVIATION 15.98 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	95 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants	163 Participants n=7 Participants	308 Participants n=5 Participants
Race/Ethnicity, Customized White	211 participants n=5 Participants	191 participants n=7 Participants	402 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	45 participants n=5 Participants	64 participants n=7 Participants	109 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	22 participants n=5 Participants	9 participants n=7 Participants	31 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	236 participants n=5 Participants	248 participants n=7 Participants	484 participants n=5 Participants
Hematologic Malignancy Status Yes	211 participants n=5 Participants	222 participants n=7 Participants	433 participants n=5 Participants
Hematologic Malignancy Status No	47 participants n=5 Participants	36 participants n=7 Participants	83 participants n=5 Participants
Prior Allogeneic Bone Marrow Transplant (BMT) Yes	54 participants n=5 Participants	51 participants n=7 Participants	105 participants n=5 Participants
Prior Allogeneic Bone Marrow Transplant (BMT) No	204 participants n=5 Participants	207 participants n=7 Participants	411 participants n=5 Participants
Uncontrolled Malignancy Status Yes	173 participants n=5 Participants	187 participants n=7 Participants	360 participants n=5 Participants
Uncontrolled Malignancy Status No	85 participants n=5 Participants	71 participants n=7 Participants	156 participants n=5 Participants
Neutropenic Status Yes	163 participants n=5 Participants	175 participants n=7 Participants	338 participants n=5 Participants
Neutropenic Status No	95 participants n=5 Participants	83 participants n=7 Participants	178 participants n=5 Participants

PRIMARY outcome

Timeframe: Through Day 42

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	Isavuconazole n=258 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=258 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
All-cause Mortality Through Day 42	18.6 percentage of participants	20.2 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Population: Modified Intent-to-treat (mITT) population consisted of ITT participants who had proven or probable IFD as determined by the DRC.

The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses. Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a \> 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42). End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC) Day 42	35.7 percentage of participants	35.7 percentage of participants
Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC) Day 84	25.2 percentage of participants	32.6 percentage of participants
Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC) End of Treatment	35.0 percentage of participants	36.4 percentage of participants

SECONDARY outcome

Timeframe: Through Day 84

Population: Intent-to-treat population

All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.

Outcome measures

Outcome measures
Measure	Isavuconazole n=258 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=258 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
All-cause Mortality Through Day 84	29.1 percentage of participants	31.0 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Overall response based on investigators' assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Population: Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by "n".

Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC. Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With a Clinical Response Assessed by the DRC Day 42 (n=139, 120)	64.0 percentage of participants	57.5 percentage of participants
Percentage of Participants With a Clinical Response Assessed by the DRC Day 84 (n=141, 124)	46.1 percentage of participants	44.4 percentage of participants
Percentage of Participants With a Clinical Response Assessed by the DRC End of Treatment (n=137, 121)	62.0 percentage of participants	60.3 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site. Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as "Not Applicable". End of treatment is the last day of study drug administration.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With a Mycological Response Assessed by the DRC Day 42	39.9 percentage of participants	39.5 percentage of participants
Percentage of Participants With a Mycological Response Assessed by the DRC Day 84	28.0 percentage of participants	36.4 percentage of participants
Percentage of Participants With a Mycological Response Assessed by the DRC End of Treatment	37.8 percentage of participants	41.1 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Population: Modified intent-to-treat population. A participant with no post-baseline radiology data with evidence of radiologic disease at Baseline was considered a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by "n".

Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With a Radiological Response Assessed by the DRC Day 42 (n=141, 128)	28.4 percentage of participants	34.4 percentage of participants
Percentage of Participants With a Radiological Response Assessed by the DRC Day 84 (n=141, 128)	22.0 percentage of participants	29.7 percentage of participants
Percentage of Participants With a Radiological Response Assessed by the DRC End of Treatment (n=141, 127)	29.1 percentage of participants	33.1 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Population: Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by "n".

Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator. Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With a Clinical Response Assessed by the Investigator Day 84 (n=140, 122)	41.4 percentage of participants	44.3 percentage of participants
Percentage of Participants With a Clinical Response Assessed by the Investigator Day 42 (n=137, 120)	64.2 percentage of participants	61.7 percentage of participants
Percentage of Participants With a Clinical Response Assessed by the Investigator End of Treatment (n=137, 121)	62.0 percentage of participants	64.5 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site. Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as "Not Applicable". End of treatment is the last day of study drug administration.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With a Mycological Response Assessed by the Investigator Day 42 (n=109, 100)	52.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With a Mycological Response Assessed by the Investigator Day 84 (n=126, 117)	35.7 percentage of participants	37.6 percentage of participants
Percentage of Participants With a Mycological Response Assessed by the Investigator End of Treatment (n=107, 100)	50.5 percentage of participants	55.0 percentage of participants

SECONDARY outcome

Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

Population: Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by "n".

Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a \< 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.

Outcome measures

Outcome measures
Measure	Isavuconazole n=143 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=129 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Percentage of Participants With a Radiological Response Assessed by the Investigator Day 42 (n=142, 128)	45.1 percentage of participants	51.6 percentage of participants
Percentage of Participants With a Radiological Response Assessed by the Investigator Day 84 (n=141, 128)	38.3 percentage of participants	41.4 percentage of participants
Percentage of Participants With a Radiological Response Assessed by the Investigator End of Treatment (n=141, 128)	43.3 percentage of participants	47.7 percentage of participants

SECONDARY outcome

Timeframe: From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.

Population: The safety analysis set consists of all randomized patients who received at least one dose of study drug according to the study drug that the participant actually received as the first dose. One participant was randomized to isavuconazole but received voriconazole treatment for the first 7 days and is included in the voriconazole arm for safety.

Outcome measures

Outcome measures
Measure	Isavuconazole n=257 Participants Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.	Voriconazole n=259 Participants Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Number of Participants With Adverse Events, Reported by System Organ Class Endocrine Disorders	5 participants	3 participants
Number of Participants With Adverse Events, Reported by System Organ Class Congenital, Familial and Genetic Disorders	3 participants	2 participants
Number of Participants With Adverse Events, Reported by System Organ Class Social Circumstances	0 participants	1 participants
Number of Participants With Adverse Events, Reported by System Organ Class Patients with ≥ 1 TEAE	247 participants	255 participants
Number of Participants With Adverse Events, Reported by System Organ Class Gastrointestinal Disorders	174 participants	180 participants
Number of Participants With Adverse Events, Reported by System Organ Class Infections and Infestations	152 participants	158 participants
Number of Participants With Adverse Events, Reported by System Organ Class General Disorders / Administration Site Conditions	148 participants	144 participants
Number of Participants With Adverse Events, Reported by System Organ Class Respiratory, Thoracic and Mediastinal Disorders	143 participants	147 participants
Number of Participants With Adverse Events, Reported by System Organ Class Metabolism and Nutrition Disorders	108 participants	121 participants
Number of Participants With Adverse Events, Reported by System Organ Class Nervous System Disorders	95 participants	89 participants
Number of Participants With Adverse Events, Reported by System Organ Class Skin and Subcutaneous Tissue Disorders	86 participants	110 participants
Number of Participants With Adverse Events, Reported by System Organ Class Investigations	85 participants	96 participants
Number of Participants With Adverse Events, Reported by System Organ Class Blood and Lymphatic System Disorders	77 participants	82 participants
Number of Participants With Adverse Events, Reported by System Organ Class Psychiatric Disorders	70 participants	86 participants
Number of Participants With Adverse Events, Reported by System Organ Class Musculoskeletal and Connective Tissue Disorders	69 participants	77 participants
Number of Participants With Adverse Events, Reported by System Organ Class Vascular Disorders	67 participants	77 participants
Number of Participants With Adverse Events, Reported by System Organ Class Renal and Urinary Disorders	55 participants	58 participants
Number of Participants With Adverse Events, Reported by System Organ Class Cardiac Disorders	43 participants	57 participants
Number of Participants With Adverse Events, Reported by System Organ Class Eye Disorders	39 participants	69 participants
Number of Participants With Adverse Events, Reported by System Organ Class Injury, Poisoning and Procedural Complications	33 participants	39 participants
Number of Participants With Adverse Events, Reported by System Organ Class Hepatobiliary Disorders	23 participants	42 participants
Number of Participants With Adverse Events, Reported by System Organ Class Immune System Disorders	20 participants	25 participants
Number of Participants With Adverse Events, Reported by System Organ Class Neoplasms benign, malignant and unspecified	19 participants	31 participants
Number of Participants With Adverse Events, Reported by System Organ Class Ear and Labyrinth Disorders	14 participants	13 participants
Number of Participants With Adverse Events, Reported by System Organ Class Reproductive System and Breast Disorders	8 participants	13 participants

Adverse Events

Isavuconazole

Serious events: 134 serious events

Other events: 227 other events

Deaths: 0 deaths

Voriconazole

Serious events: 149 serious events

Other events: 228 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Head Immunology, Transplant and Infectious Disease Therapeutic Area

Astellas Pharma Global Development, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.
Publication restrictions are in place

Restriction type: OTHER