A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.

This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting.

Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first.

De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.

• Isavuconazole (Drug), also known as Cresemba: antifungal agent

Primary outcomes

• Number of Participants With Clinical Response at Week 6 [Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Clinical Response at Week 12 [Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Clinical Response at Week 24 [Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Radiological Response at Week 6 [Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Radiological Response at Week 12 [Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: >= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Radiological Response at Week 24 [Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: >= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Mycological Response at Week 6 [Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Mycological Response at Week 12 [Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Mycological Response at Week 24 [Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• All-Cause Mortality at Week 6 [Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• All-Cause Mortality at Week 12 [Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants who died due to any cause at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• All-Cause Mortality at Week 24 [Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants who died due to any cause at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Adverse Event at Week 6 [Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Adverse Event at Week 12 [Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Adverse Event at Week 24 [Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Serious Adverse Event at Week 6 [Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Serious Adverse Event at Week 12 [Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Serious Adverse Event at Week 24 [Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.

Secondary outcomes

• Number of Participants According to Method of Administration [At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months]: Number of participants according to method of drug administration: infusion, oral and unknown were reported in this outcome measure.
• Number of Participants According to Dosage of Isavuconazole Administration [At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months]: Number of participants according to dosage of drug administration: 200 milligram (mg), other and unknown were reported in this outcome measure.
• Number of Participants With Therapeutic Drug Monitoring (TDM) [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Isavuconazole Treatment Modification [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Treatment modification was defined as change in dose or dosing schedule of participants who received isavuconazole. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Types of Isavuconazole Treatment Modification [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants with type of treatment modifications required during the index period were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Duration Between Isavuconazole Treatment and Treatment Modification [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Duration between Isavuconazole treatment and treatment modification was defined as the date of first modification minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Percentage of Participants Who Discontinued Isavuconazole Treatment [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Percentage of participants who discontinued Isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Duration of Isavuconazole Treatment [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Duration between Isavuconazole treatment was defined as the date of discontinuation minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Reasons for Isavuconazole Treatment Discontinuation [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants with reasons for Isavuconazole treatment discontinuation were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants Who Switched to New Antifungal [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants who switched to new antifungal therapy after discontinuation of Isavuconazole were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Type of New Antifungal Therapy [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants according to new antifungal therapy after end of isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Isavuconazole Administered as Part of Combination Therapy [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants with index treatment administered as part of antifungal combination therapy were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. one participant could have received more than one treatment
• Number of Participants Who Received Other Concomitant Treatments [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Concomitant treatments included: Antibiotic agent, corticosteroid agent, chemotherapy, immunosuppressant agent, other and unknown were reported in this outcome measure. One participant could have more than one treatment. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Any Outpatient Visits [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants with any outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Total Number of Outpatient Visits [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Total number of outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Type of Outpatient Visits [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Type of outpatient visit (Health Care Professional Visit or Referral) such as secondary care visit (specialist), secondary care referral (specialist), primary care visit (general practitioner) and emergency room (ER) visit were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Duration between Isavuconazole treatment was defined as the date of first outpatient visit minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Inpatient Hospitalization [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants according to index treatment administered in the inpatient setting were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants With Primary Reason For Inpatient Hospitalization [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants with primary reason for inpatient hospitalization such as other disease monitoring, other, invasive aspergillosis or mucormycosis disease monitoring, AE related to invasive aspergillosis or mucormycosis and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Duration between Isavuconazole treatment was defined as the date of inpatient hospitalization minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Mean Length of Stay For Inpatient Hospitalization [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Length of stay was computed as the date of discharge from hospital minus the date of hospitalization plus (+) 1. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
• Number of Participants According to Location for Inpatient Hospitalization [From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)]: Number of participants according to location for inpatient hospitalization such as: hematology ward, other ward, intensive care unit, transplantation ward, emergency room, general medicine ward, oncology ward and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
2. Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )
3. Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)

Exclusion Criteria:

1\. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period

Participant flow

Outcome results

• Number of Participants With Clinical Response at Week 6 (Primary), Count of participants, Participants: Invasive Aspergillosis 173; Mucormycosis 14
• Number of Participants With Clinical Response at Week 12 (Primary), Count of participants, Participants: Invasive Aspergillosis 185; Mucormycosis 15
• Number of Participants With Clinical Response at Week 24 (Primary), Count of participants, Participants: Invasive Aspergillosis 193; Mucormycosis 17
• Number of Participants With Radiological Response at Week 6 (Primary), Count of participants, Participants: Invasive Aspergillosis 188; Mucormycosis 14
• Number of Participants With Radiological Response at Week 12 (Primary), Count of participants, Participants: Invasive Aspergillosis 190; Mucormycosis 16
• Number of Participants With Radiological Response at Week 24 (Primary), Count of participants, Participants: Invasive Aspergillosis 195; Mucormycosis 16
• Number of Participants With Mycological Response at Week 6 (Primary), Count of participants, Participants: Invasive Aspergillosis 190; Mucormycosis 17
• Number of Participants With Mycological Response at Week 12 (Primary), Count of participants, Participants: Invasive Aspergillosis 195; Mucormycosis 17
• Number of Participants With Mycological Response at Week 24 (Primary), Count of participants, Participants: Invasive Aspergillosis 198; Mucormycosis 17
• All-Cause Mortality at Week 6 (Primary), Count of participants, Participants: Invasive Aspergillosis 48; Mucormycosis 1
• All-Cause Mortality at Week 12 (Primary), Count of participants, Participants: Invasive Aspergillosis 74; Mucormycosis 2
• All-Cause Mortality at Week 24 (Primary), Count of participants, Participants: Invasive Aspergillosis 93; Mucormycosis 5
• Number of Participants With Adverse Event at Week 6 (Primary), Count of participants, Participants: Invasive Aspergillosis 33; Mucormycosis 2
• Number of Participants With Adverse Event at Week 12 (Primary), Count of participants, Participants: Invasive Aspergillosis 38; Mucormycosis 3
• Number of Participants With Adverse Event at Week 24 (Primary), Count of participants, Participants: Invasive Aspergillosis 42; Mucormycosis 3
• Number of Participants With Serious Adverse Event at Week 6 (Primary), Count of participants, Participants: Invasive Aspergillosis 26; Mucormycosis 2
• Number of Participants With Serious Adverse Event at Week 12 (Primary), Count of participants, Participants: Invasive Aspergillosis 30; Mucormycosis 3
• Number of Participants With Serious Adverse Event at Week 24 (Primary), Count of participants, Participants: Invasive Aspergillosis 34; Mucormycosis 3
• Number of Participants According to Method of Administration (Secondary), Count of participants, Participants: Invasive Aspergillosis 105; Mucormycosis 8
• Number of Participants According to Dosage of Isavuconazole Administration (Secondary), Count of participants, Participants: Invasive Aspergillosis 186; Mucormycosis 17
• 20 more outcome measures not shown.

Adverse events

Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months); Index date: date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019

Serious adverse events by term

Other adverse events by term

• Results publication: Neofytos D, Pagliuca A, Houghton K, Broughton E, de Figueiredo Valente MLN, Jiang L, Enoch DA, Gruener B, Herbrecht R, Lahmer T, Lortholary O, Melenotte C, De Rosa FG, Garcia-Vidal C, Jimenez M, Fernandez M, Cornely O. Effectiveness, Safety, and Patterns of Real-World Isavuconazole Use in Europe (2015-2019). Infect Dis Ther. 2024 Dec;13(12):2527-2543. doi: 10.1007/s40121-024-01064-4. Epub 2024 Oct 24. PMID 39443403

• Study Protocol (PDF, 2020-07-27)
• Statistical Analysis Plan (PDF, 2020-09-16)

• Pfizer CT.gov Call Center, Study director, Pfizer