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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILDENAFIL | Patients taking SILDENAFIL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SILDENAFIL | Drug | Revatio® Tablets 20 mg Dosage, Frequency: According to Japanese LPD, "For oral use, the adult dose is 20 mg three times a day". Duration: According to the protocol of A1481263, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 3 years after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator. | 3 years |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator. | 3 years |
| Number of Paritcipants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events. | 3 years |
| Number of Paritcipants With Treatment-Related Adverse Events by Gender | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Revatio (Sildenafil Citrate) | Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 3304 participants received sildenafil citrate at least once in this study. Of the 3304 participants, 33 participants were excluded from the baseline analysis due to following reasons: protocol violation, no visit after first day of treatment, safety not assessable and no drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | Revatio (Sildenafil Citrate) | Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. 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 Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once. | Posted | Number | Participants | 3 years |
|
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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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event 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 | Revatio (Sildenafil Citrate) | Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 18.1 | 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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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
| 3 years |
| Number of Participants With Treatment-Related Adverse Events by Disease Type | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis". | 3 years |
| Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events. | 3 years |
| Clinical Efficacy Rate by Age | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness. | 3 years |
| Clinical Efficacy Rate by Gender | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness. | 3 years |
| Clinical Efficacy Rate by Disease Type | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis". | 3 years |
| Clinical Efficacy Rate by WHO Functional Classificaton of Severity | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness. | 3 years |
| No Drug Administration |
|
| Participants |
|
| Age, Customized | Number | Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Disease Type | Categorization of PAH in the study. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis". | Number | Participants |
|
| WHO Functional Classification of PAH | This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH. | Number | Participants |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Primary | Number of Paritcipants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once. | Posted | Number | Paritcipants | 3 years |
|
|
|
| Primary | Number of Paritcipants With Treatment-Related Adverse Events by Gender | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once. | Posted | Number | Paritcipants | 3 years |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events by Disease Type | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis". | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Primary | Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity | A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Primary | Clinical Efficacy Rate by Age | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness. | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table. | Posted | Number | Percentage of Participants | 3 years |
|
|
|
| Primary | Clinical Efficacy Rate by Gender | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness. | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table. | Posted | Number | Percentage of Participants | 3 years |
|
|
|
| Primary | Clinical Efficacy Rate by Disease Type | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis". | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table. | Posted | Number | Percentage of Participants | 3 years |
|
|
|
| Primary | Clinical Efficacy Rate by WHO Functional Classificaton of Severity | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness. | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table. | Posted | Number | Percentage of Participants | 3 years |
|
|
|
| 982 |
| 3,304 |
| 509 |
| 3,304 |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastroenteritis adenovirus | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatitis A | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary mycosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Septic embolus | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Infusion site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Phlebitis infective | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Wound abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Serratia infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Puncture site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Varicella zoster pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Borderline ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Gingival cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to gallbladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| POEMS syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Abnormal clotting factor | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Allergic granulomatous angiitis | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Self injurious behaviour | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Clonic convulsion | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Neuropsychiatric lupus | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Seizure anoxic | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Spastic paralysis | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac valve disease | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Low cardiac output syndrome | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pericarditis constrictive | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diffuse panbronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Fibrinous bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary haemosiderosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary hypertensive crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary vein occlusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary veno-occlusive disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Oesophageal fistula | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Portal venous gas | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Protein-losing gastroenteropathy | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Biliary cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemorrhage subepidermal | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Scleroderma renal crisis | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anomalous pulmonary venous connection | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Congenital diaphragmatic hernia | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Congenital mitral valve stenosis | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Familial mediterranean fever | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Interruption of aortic arch | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Mitochondrial myopathy | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Persistent foetal circulation | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary arteriovenous fistula | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary artery atresia | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary hypoplasia | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Catheter site induration | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Device breakage | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Device connection issue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Device damage | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Device pacing issue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Food interaction | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Blood glucose abnormal | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Carbon dioxide increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac output decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Computerised tomogram thorax abnormal | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary arterial pressure increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Catheter removal | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung transplant | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
| Skin operation | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
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.
| D002318 |
| Cardiovascular Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| PVOD/PCH** (n=44) |
|
| Persistent PH of the Newborn (PPHN) (n=59) |
|
| Other PAH (n=139) |
|
| Other Than PAH (n=665) |
|
| Unkown (n=1) |
|
| Title | Measurements |
|---|---|
|
| Class IV (n=545) |
|
| Not Classified (n=124) |
|
| Title | Measurements |
|---|---|
|
| PVOD/PCH** (n=44) |
|
| Persistent PH of the Newborn (PPHN) (n=59) |
|
| Other PAH (n=139) |
|
| Other Than PAH (n=665) |
|
| Unknown (n=1) |
|
| Title | Measurements |
|---|---|
|
| Class IV (n=544) |
|
| Not Classified (n=124) |
|