Trial Outcomes & Findings for Vfend Special Investigation For Prophylaxis (NCT NCT02674685)

NCT ID: NCT02674685

Last Updated: 2023-04-25

Results Overview

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

241 participants

Primary outcome timeframe

Maximum 3 years

Results posted on

2023-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	VFEND (Voriconazole) Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	241
Overall Study COMPLETED	237
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	VFEND (Voriconazole) Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VFEND (Voriconazole) n=233 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	79 Participants n=233 Participants
Age, Customized ≥15 and <65 years	128 Participants n=233 Participants
Age, Customized ≥65 years	26 Participants n=233 Participants
Sex: Female, Male Female	96 Participants n=233 Participants
Sex: Female, Male Male	137 Participants n=233 Participants
Reason for Use Primary prophylaxis	216 Participants n=233 Participants
Reason for Use Secondary prophylaxis	16 Participants n=233 Participants
Reason for Use Others	1 Participants n=233 Participants

PRIMARY outcome

Timeframe: Maximum 3 years

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=233 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions ADR	62 Participants
Number of Participants With Adverse Drug Reactions Serious ADR	5 Participants

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=233 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions)	6 Participants

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by age (\<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=233 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants With Adverse Drug Reactions by Age <15 years	20.25 Percentage of Participants Interval 12.043 to 30.796
Proportion of Participants With Adverse Drug Reactions by Age ≥15 years	29.87 Percentage of Participants Interval 22.77 to 37.763

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by reason for use to assess whether it was a risk factor for the occurrence of ADRs.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=233 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants With Adverse Drug Reactions by Reason for Use Primary prophylaxis	26.39 Percentage of Participants Interval 20.641 to 32.797
Proportion of Participants With Adverse Drug Reactions by Reason for Use Secondary prophylaxis	31.25 Percentage of Participants Interval 11.017 to 58.662
Proportion of Participants With Adverse Drug Reactions by Reason for Use Others	0.00 Percentage of Participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by long-term use to assess whether it was a risk factor for the occurrence of ADRs.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=233 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants With Adverse Drug Reactions by Long-term Use <180 days	24.56 Percentage of Participants Interval 18.311 to 31.715
Proportion of Participants With Adverse Drug Reactions by Long-term Use ≥180 days	32.26 Percentage of Participants Interval 20.94 to 45.336

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.

IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=198 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate)	1.5 Percentage of Participants Interval 0.31 to 4.36

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.

IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by age (\<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=198 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age <15 years	1.5 Percentage of Participants Interval 0.04 to 7.92
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age ≥15 years	1.5 Percentage of Participants Interval 0.19 to 5.45

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.

IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=198 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use Primary prophylaxis	1.1 Percentage of Participants Interval 0.13 to 3.87
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use Secondary prophylaxis	7.1 Percentage of Participants Interval 0.18 to 33.87

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.

Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=198 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate)	97.5 Percentage of Participants Interval 94.21 to 99.18

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.

Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by age (\<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=198 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age <15 years	98.5 Percentage of Participants Interval 92.08 to 99.96
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age ≥15 years	96.9 Percentage of Participants Interval 92.31 to 99.16

SECONDARY outcome

Timeframe: Maximum 3 years

Population: The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.

Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.

Outcome measures

Outcome measures
Measure	VFEND (Voriconazole) n=198 Participants Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use Primary prophylaxis	97.8 Percentage of Participants Interval 94.53 to 99.4
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use Secondary prophylaxis	92.9 Percentage of Participants Interval 66.13 to 99.82

Adverse Events

VFEND (Voriconazole)

Serious events: 60 serious events

Other events: 153 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	VFEND (Voriconazole) n=233 participants at risk Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Infections and infestations Adenovirus infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia influenzal	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Cytomegalovirus viraemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Staphylococcal sepsis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Herpes virus infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Meningoencephalitis herpetic	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Bacteraemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Psoas abscess	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Tooth infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Systemic candida	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Systemic mycosis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Sepsis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Lung abscess	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia recurrent	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Anaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Bone marrow failure	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Febrile neutropenia	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Acute graft versus host disease	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Acute graft versus host disease in intestine	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Acute graft versus host disease in liver	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Cytokine storm	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Engraftment syndrome	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Graft versus host disease	5.2% 12/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Graft versus host disease in lung	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Primary amyloidosis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Tumour lysis syndrome	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Cerebrovascular accident	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Headache	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Parkinsonism	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Arrhythmia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure acute	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure chronic	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Shock	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Idiopathic pneumonia syndrome	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Diarrhoea	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Pancreatitis acute	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Cholecystitis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatic function abnormal	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatitis acute	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Venoocclusive liver disease	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Acute kidney injury	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Nephrotic syndrome	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal disorder	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal failure	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal impairment	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Generalised oedema	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Mucosal inflammation	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Multiple organ dysfunction syndrome	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Aspartate aminotransferase increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood bilirubin increased	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood creatinine increased	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood urea increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Neutrophil count decreased	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Platelet count decreased	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Engraft failure	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	VFEND (Voriconazole) n=233 participants at risk Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
Blood and lymphatic system disorders Anaemia	3.4% 8/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Bone marrow failure	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Eosinophilia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Febrile neutropenia	14.2% 33/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Leukopenia	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Neutropenia	3.4% 8/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Pancytopenia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Thrombocytopenia	4.3% 10/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Photophobia	3.9% 9/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Photopsia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Visual impairment	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Abdominal pain	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Diarrhoea	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Dyschezia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Nausea	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Oral disorder	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Stomatitis	2.6% 6/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Vomiting	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Mucosal disorder	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Oedema	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Pyrexia	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Bile duct stone	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Cholecystitis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Cholelithiasis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Cholestasis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatic function abnormal	3.4% 8/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatotoxicity	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Liver disorder	6.0% 14/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Venoocclusive liver disease	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Acute graft versus host disease	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Acute graft versus host disease in intestine	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Acute graft versus host disease in skin	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Anaphylactic reaction	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Engraftment syndrome	3.0% 7/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Graft versus host disease	13.3% 31/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Graft versus host disease in liver	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Graft versus host disease in skin	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Hypogammaglobulinaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Aspergillus infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Bacterial infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Candida infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Cellulitis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Cytomegalovirus infection	1.3% 3/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Cytomegalovirus viraemia	4.3% 10/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Fungal infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Gastroenteritis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Herpes zoster	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Oesophageal candidiasis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Oral herpes	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Sepsis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Skin infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Tongue fungal infection	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Alanine aminotransferase decreased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Alanine aminotransferase increased	10.3% 24/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Aspartate aminotransferase increased	9.9% 23/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood alkaline phosphatase increased	8.2% 19/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood beta-D-glucan increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood bilirubin increased	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood creatinine increased	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood lactate dehydrogenase increased	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood pressure increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood urea increased	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Brain natriuretic peptide increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations C-reactive protein increased	3.9% 9/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Drug level increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Electrocardiogram QT prolonged	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Gamma-glutamyltransferase increased	12.9% 30/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations International normalised ratio increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Neutrophil count decreased	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Platelet count decreased	5.2% 12/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Serum ferritin increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Transaminases increased	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations White blood cell count decreased	5.2% 12/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations White blood cell count increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Decreased appetite	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hypochloraemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyponatraemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Steroid diabetes	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Back pain	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Bone formation increased	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Myopathy	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Headache	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Peripheral sensory neuropathy	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Delirium	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Depression	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Hallucination, auditory	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Hallucination, visual	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Insomnia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Azotaemia	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Cystitis haemorrhagic	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Hydronephrosis	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal impairment	2.1% 5/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.43% 1/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Drug eruption	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Pruritus	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Rash	1.7% 4/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Hypertension	0.86% 2/233 • 3 years at Maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

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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 publications 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