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Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | 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. | Maximum 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects who have been treated with voriconazole for prophylaxis of invasive fungal infections in patients undergoing HSCT (Hematopoietic Stem Cell Transplantation)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 237 participants completed this study. Of the 237 participants, 4 participants were excluded from the safety analysis set due to the following reasons: Protocol violation (registration violation, 3; contract violation/deficiency, 1)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | Participants | Maximum 3 years |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenovirus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2015 | Jul 2, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2019 | Jul 2, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Maximum 3 years |
| Proportion of Participants With Adverse Drug Reactions by Age | 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. | Maximum 3 years |
| Proportion of Participants With Adverse Drug Reactions by Reason for Use | 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. | Maximum 3 years |
| Proportion of Participants With Adverse Drug Reactions by Long-term Use | 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. | Maximum 3 years |
| Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) | 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. | Maximum 3 years |
| Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age | 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. | Maximum 3 years |
| Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use | 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. | Maximum 3 years |
| Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) | 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. | Maximum 3 years |
| Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age | 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. | Maximum 3 years |
| Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use | 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. | Maximum 3 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Reason for Use | Primary prophylaxis: Prophylaxis in participants without history of fungal infection. Secondary prophylaxis: Prophylaxis in participants with history of fungal infection. | Number | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants With Adverse Drug Reactions by Age | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants With Adverse Drug Reactions by Reason for Use | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants With Adverse Drug Reactions by Long-term Use | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| Secondary | Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Maximum 3 years |
|
|
|
| 19 |
| 233 |
| 60 |
| 233 |
| 153 |
| 233 |
| Pneumonia influenzal | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Meningoencephalitis herpetic | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Systemic mycosis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Chronic myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Acute graft versus host disease | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Acute graft versus host disease in liver | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cytokine storm | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Graft versus host disease in lung | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Primary amyloidosis | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Idiopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Engraft failure | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Mucosal disorder | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Acute graft versus host disease | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Acute graft versus host disease in skin | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Engraftment syndrome | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Graft versus host disease | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Graft versus host disease in liver | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Graft versus host disease in skin | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hypogammaglobulinaemia | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Aspergillus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Candida infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Cytomegalovirus viraemia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Tongue fungal infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Alanine aminotransferase decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood beta-D-glucan increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Brain natriuretic peptide increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Drug level increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Serum ferritin increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Steroid diabetes | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Bone formation increased | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
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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.
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