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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 Mycobutin® 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 |
|---|---|---|---|
| rifabutin | Patients administered Rifabutin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rifabutin | Drug | Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " 1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily. 2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily". |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. | 1 year |
| 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 Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator. | 1 year |
| Number of Participants With Treatment-Related Adverse Events by Diagnosis | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events. | 1 year |
| Number of Participants With Treatment-Related Adverse Events by Gender | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events. | 1 year |
| Number of Participants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A0061006 prescribes the Mycobutin®).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total 628 subjects were registered in this study. Of the 628 subjects, 594 subjects CRFs were collected and included in the study. Of the 594 subjects, 6 subjects were excluded from the safety analysis set (SAS). In total, 588 subjects were included in the SAS as the completed the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Mycobutin (Rifabutin) | Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 588 participants received Mycobutin at least once in this study. Of the 594 participants, 6 participants were excluded from the baseline analysis due to following reasons: protocol violation and no visit after first day of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mycobutin (Rifabutin) | Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. 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 | Count of Participants |
| 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 Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once. | Posted | Count of Participants | Participants | 1 year |
|
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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 | Mycobutin (Rifabutin) | Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver disorder | Hepatobiliary disorders | MedDRA 19.0 | 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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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Not provided
| ID | Term |
|---|---|
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 1 year |
| Clinical Efficacy Rate | 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 along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. | 1 year |
| Clinical Efficacy Rate by Diagnosis | 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 along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness. | 1 year |
| 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 Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness. | 1 year |
| 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 Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness. | 1 year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|
| 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 Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events by Diagnosis | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events by Gender | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Primary | Clinical Efficacy Rate | 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 along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 year |
|
|
|
| Primary | Clinical Efficacy Rate by Diagnosis | 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 along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute 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 | 95% Confidence Interval | Percentage of Participants | 1 year |
|
|
|
| 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 Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute 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 | 1 year |
|
|
|
| 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 Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute 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 | 1 year |
|
|
|
| 184 |
| 588 |
| 470 |
| 588 |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Aspergillus infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pneumonia pseudomonal | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pulmonary mycosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Waldenstrom's macroglobulinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tonic convulsion | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Optic neuropathy | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastrointestinal amyloidosis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug interaction | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 19.0 | 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.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
|
| Non-tuberculous Mycobacteria Other Than MAC |
|
|
| Coinfection |
|
|
| Others |
|
|
|
|
| ≥65 years |
|
|
| Unknown |
|
|
| Cochran-Armitage (EXACT) |
| 0.428 |
| Superiority or Other |
|
| Non-tuberculous Mycobacteria Other Than MAC |
|
|
| Coinfection |
|
|
| Others |
|
|
|
|
| ≥65 years |
|
|
| Unknown |
|
|