Trial Outcomes & Findings for A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions. (NCT NCT04550936)
NCT ID: NCT04550936
Last Updated: 2025-12-09
Results Overview
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.
COMPLETED
307 participants
Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
2025-12-09
Participant Flow
Data from the medical records of participants with invasive aspergillosis or mucormycosis who initiated isavuconazole treatment during the index period of 15 October 2015 until 30 June 2019 were included in this study.
Retrospective data was extracted and evaluated from study start date and until study completion (approximately 34 months) of this retrospective observational study. Participants were followed from index date until 6 months post-index treatment discontinuation, death, loss to follow-up, whichever occurs first.
Participant milestones
| Measure |
Invasive Aspergillosis
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
17
|
|
Overall Study
COMPLETED
|
201
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION 15.6 • n=201 Participants
|
66.5 Years
STANDARD_DEVIATION 12.8 • n=17 Participants
|
56.8 Years
STANDARD_DEVIATION 15.6 • n=218 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=201 Participants
|
9 Participants
n=17 Participants
|
74 Participants
n=218 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=201 Participants
|
8 Participants
n=17 Participants
|
144 Participants
n=218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Clinical Response at Week 6
Unknown
|
173 Participants
|
14 Participants
|
|
Number of Participants With Clinical Response at Week 6
Clinical success
|
27 Participants
|
3 Participants
|
|
Number of Participants With Clinical Response at Week 6
Clinical failure
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Clinical Response at Week 12
Clinical failure
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Response at Week 12
Unknown
|
185 Participants
|
15 Participants
|
|
Number of Participants With Clinical Response at Week 12
Clinical success
|
16 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Clinical Response at Week 24
Unknown
|
193 Participants
|
17 Participants
|
|
Number of Participants With Clinical Response at Week 24
Clinical success
|
8 Participants
|
0 Participants
|
|
Number of Participants With Clinical Response at Week 24
Clinical failure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Radiological Response at Week 6
Unknown
|
188 Participants
|
14 Participants
|
|
Number of Participants With Radiological Response at Week 6
Radiological success
|
11 Participants
|
3 Participants
|
|
Number of Participants With Radiological Response at Week 6
Radiological failure
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Radiological Response at Week 12
Radiological success
|
9 Participants
|
1 Participants
|
|
Number of Participants With Radiological Response at Week 12
Unknown
|
190 Participants
|
16 Participants
|
|
Number of Participants With Radiological Response at Week 12
Radiological failure
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Radiological Response at Week 24
Unknown
|
195 Participants
|
16 Participants
|
|
Number of Participants With Radiological Response at Week 24
Radiological success
|
4 Participants
|
0 Participants
|
|
Number of Participants With Radiological Response at Week 24
Radiological failure
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Mycological Response at Week 6
Unknown
|
190 Participants
|
17 Participants
|
|
Number of Participants With Mycological Response at Week 6
Mycological Success: Presumed eradication
|
7 Participants
|
0 Participants
|
|
Number of Participants With Mycological Response at Week 6
Mycological Success: Eradication
|
4 Participants
|
0 Participants
|
|
Number of Participants With Mycological Response at Week 6
Mycological Failure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Mycological Response at Week 12
Unknown
|
195 Participants
|
17 Participants
|
|
Number of Participants With Mycological Response at Week 12
Mycological Success: Presumed eradication
|
3 Participants
|
0 Participants
|
|
Number of Participants With Mycological Response at Week 12
Mycological Success: Eradication
|
3 Participants
|
0 Participants
|
|
Number of Participants With Mycological Response at Week 12
Mycological Failure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Mycological Response at Week 24
Unknown
|
198 Participants
|
17 Participants
|
|
Number of Participants With Mycological Response at Week 24
Mycological Success: Presumed eradication
|
1 Participants
|
0 Participants
|
|
Number of Participants With Mycological Response at Week 24
Mycological Success: Eradication
|
0 Participants
|
0 Participants
|
|
Number of Participants With Mycological Response at Week 24
Mycological Failure
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
All-Cause Mortality at Week 6
|
48 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
All-Cause Mortality at Week 12
|
74 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
All-Cause Mortality at Week 24
|
93 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Adverse Event at Week 6
|
33 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Adverse Event at Week 12
|
38 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Adverse Event at Week 24
|
42 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Serious Adverse Event at Week 6
|
26 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Serious Adverse Event at Week 12
|
30 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Serious Adverse Event at Week 24
|
34 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
Number of participants according to method of drug administration: infusion, oral and unknown were reported in this outcome measure.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants According to Method of Administration
Infusion
|
105 Participants
|
8 Participants
|
|
Number of Participants According to Method of Administration
Oral
|
92 Participants
|
9 Participants
|
|
Number of Participants According to Method of Administration
Unknown
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
Number of participants according to dosage of drug administration: 200 milligram (mg), other and unknown were reported in this outcome measure.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants According to Dosage of Isavuconazole Administration
200 mg
|
186 Participants
|
17 Participants
|
|
Number of Participants According to Dosage of Isavuconazole Administration
Other
|
10 Participants
|
0 Participants
|
|
Number of Participants According to Dosage of Isavuconazole Administration
Unknown
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Therapeutic Drug Monitoring (TDM)
|
33 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Isavuconazole Treatment Modification
|
24 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=24 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=2 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Change from infusion to oral capsule
|
13 Participants
|
1 Participants
|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Frequency decrease
|
15 Participants
|
0 Participants
|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Other
|
14 Participants
|
1 Participants
|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Dose increase
|
11 Participants
|
0 Participants
|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Dose decrease
|
6 Participants
|
1 Participants
|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Change from oral capsule to infusion
|
4 Participants
|
0 Participants
|
|
Number of Participants With Types of Isavuconazole Treatment Modification
Frequency increase
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=23 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=2 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Duration Between Isavuconazole Treatment and Treatment Modification
|
38.6 Days
Standard Deviation 59.4
|
21.5 Days
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Isavuconazole Treatment
|
93.0 Percentage of Participants
|
94.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=187 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=16 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Duration of Isavuconazole Treatment
|
74.4 Days
Standard Deviation 121.7
|
115.6 Days
Standard Deviation 97.5
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=187 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=16 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Participant completed planned course of treatment
|
40 Participants
|
8 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Treatment success (resolution of invasive fungal infection)
|
33 Participants
|
1 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Other
|
17 Participants
|
1 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Lack of response to treatment
|
12 Participants
|
1 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Unknown
|
9 Participants
|
1 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Adverse event
|
7 Participants
|
2 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Participant decision (unrelated to AEs)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Drug-drug interaction
|
3 Participants
|
0 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Therapeutic drug monitoring
|
1 Participants
|
0 Participants
|
|
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Death (unrelated to therapy)
|
75 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants Who Switched to New Antifungal
|
34 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=34 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=2 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Type of New Antifungal Therapy
Liposomal amphotericin B
|
10 Participants
|
1 Participants
|
|
Number of Participants With Type of New Antifungal Therapy
Voriconazole
|
6 Participants
|
0 Participants
|
|
Number of Participants With Type of New Antifungal Therapy
Caspofungin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Type of New Antifungal Therapy
Posaconazole
|
12 Participants
|
1 Participants
|
|
Number of Participants With Type of New Antifungal Therapy
Other
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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
Outcome measures
| Measure |
Invasive Aspergillosis
n=254 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=44 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Isavuconazole Administered as Part of Combination Therapy
|
53 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=254 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=44 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants Who Received Other Concomitant Treatments
Corticosteroid agent
|
17 Participants
|
2 Participants
|
|
Number of Participants Who Received Other Concomitant Treatments
Chemotherapy
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Received Other Concomitant Treatments
Antibiotic agent
|
109 Participants
|
16 Participants
|
|
Number of Participants Who Received Other Concomitant Treatments
Immunosuppressant agent
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Received Other Concomitant Treatments
Other
|
5 Participants
|
3 Participants
|
|
Number of Participants Who Received Other Concomitant Treatments
Unknown
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Any Outpatient Visits
|
87 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Total Number of Outpatient Visits
|
103 Outpatient visits
|
12 Outpatient visits
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=87 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=9 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Type of Outpatient Visits
Secondary care visit (specialist)
|
70 Participants
|
9 Participants
|
|
Type of Outpatient Visits
Secondary care referral (specialist)
|
15 Participants
|
1 Participants
|
|
Type of Outpatient Visits
Primary care visit (general practitioner)
|
6 Participants
|
0 Participants
|
|
Type of Outpatient Visits
ER visit
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=85 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=8 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit
|
63.0 Days
Standard Deviation 78.2
|
82.6 Days
Standard Deviation 128.0
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Inpatient Hospitalization
|
114 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=114 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=14 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants With Primary Reason For Inpatient Hospitalization
Other disease monitoring
|
83 Participants
|
8 Participants
|
|
Number of Participants With Primary Reason For Inpatient Hospitalization
Unknown
|
2 Participants
|
0 Participants
|
|
Number of Participants With Primary Reason For Inpatient Hospitalization
Other
|
31 Participants
|
6 Participants
|
|
Number of Participants With Primary Reason For Inpatient Hospitalization
Invasive aspergillosis or mucormycosis disease monitoring
|
27 Participants
|
2 Participants
|
|
Number of Participants With Primary Reason For Inpatient Hospitalization
AE related to invasive aspergillosis or mucormycosis
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=113 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=13 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization
|
65.2 Days
Standard Deviation 108.8
|
77.2 Days
Standard Deviation 125.1
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=113 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=13 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Mean Length of Stay For Inpatient Hospitalization
|
20.8 Days
Standard Deviation 44.3
|
20.0 Days
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: 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)Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
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.
Outcome measures
| Measure |
Invasive Aspergillosis
n=201 Participants
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 Participants
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Number of Participants According to Location for Inpatient Hospitalization
Other ward
|
40 Participants
|
5 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
Transplantation ward
|
14 Participants
|
1 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
Emergency room (ER)
|
9 Participants
|
3 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
General medicine ward
|
9 Participants
|
0 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
Oncology ward
|
6 Participants
|
2 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
Unknown
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
Haematology ward
|
61 Participants
|
6 Participants
|
|
Number of Participants According to Location for Inpatient Hospitalization
Intensive unit care (ICU)
|
21 Participants
|
1 Participants
|
Adverse Events
Invasive Aspergillosis
Mucormycosis
Serious adverse events
| Measure |
Invasive Aspergillosis
n=201 participants at risk
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 participants at risk
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Clostridium difficile infection
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Acute Gastrointestinal, Graft-versus-host disease (GVHD)
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Allergic reaction
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Multiorgan failure
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Anorexia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Paraesthesia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Hemoptosis
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Delerium
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Myopathy
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Intracerebral haemorrhage
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Septic shock
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Bacteraemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Infection
|
1.00%
2/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Progression of Invasive fungal disease
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Hypogammaglobulinaemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Thrombocytopaenia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Haematological recurrence
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Hypokalaemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Hyperkalaemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Neutropaenia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Gamma-glutamyl transferase
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Abnormal liver chemistry test
|
2.5%
5/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.5%
7/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Cardio-respiratory shock
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Cardiac disorders
Cardio-respiratory Failure
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Cardiac disorders
Tachycardia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Surgical and medical procedures
Stem cell transplantation
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Surgical and medical procedures
Surgery
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Surgical and medical procedures
Aspergillosis cyst removal
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Choreotinitis
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Castelman's disease relapse
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Renal failure
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Death
|
7.5%
15/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Other adverse events
| Measure |
Invasive Aspergillosis
n=201 participants at risk
Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
Mucormycosis
n=17 participants at risk
Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.00%
2/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Nausea
|
1.00%
2/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Phlebitis
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Peripheral oedema
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Fatigue
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Hypoacusis
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Myopathy
|
1.00%
2/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Hallucinations
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Bacteraemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Hypogammaglobulinaemia
|
0.00%
0/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.00%
2/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Thrombocytopaenia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Hypokalaemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Hyperkalaemia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Neutropaenia
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Gamma-glutamyl transferase increase
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Abnormal liver chemistry test
|
1.5%
3/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.50%
1/201 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • 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
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during 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