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Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone | Patients with CHF receiving Selara (eplerenone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | In adults, usually, administer the initial dose of 25 mg once daily according to the patient's serum potassium level and conditions, increase dosage up to 50 mg once daily after 4 week; patients with moderate renal impairment should start with 25 mg every other day and the maximum dosage should be 25 mg once daily. Also, dose should be reduced or interrupted according to serum potassium level and patient's conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant with moderate renal impairment (≥30 mL/min and <50 mL/min in eCLCr) who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician. | 52 weeks from the start date |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Local Country Office | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Selara Tablets (Eplerenone) | Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 1165 participants were enrolled in this study. Of the 1164 participants who completed the study, 25 participants were excluded from the safety analysis set due to the following reasons: protocol violation (16 participants), and no adverse event information (no visit after first day of treatment or unknown) (9 participants).
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| ID | Title | Description |
|---|---|---|
| BG000 | Selara Tablets (Eplerenone) | Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. 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 | Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant with moderate renal impairment (≥30 mL/min and <50 mL/min in eCLCr) who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician. | The safety analysis set comprised of chronic heart failure participants who satisfied the inclusion criteria and had received Selara at least once. Of the participants included in the safety analysis set (n=1139), 316 participants had moderate renal impairment (≥30 mL/min and <50 mL/min in eCLCr). | Posted | Number | Percentage of Participants | 52 weeks from the start date |
|
52 weeks from the start date
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selara Tablets (Eplerenone) | Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 22.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2018 | Jun 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2020 | Jun 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
|
| 52 weeks from the start date |
| The Number of Deaths (Overall Deaths) | Overall deaths were described with the number of deaths from any cause at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | 52 weeks from the start date |
| The Number of Deaths (Cardiovascular Deaths) | Cardiovascular deaths were described with the number of deaths defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | 52 weeks from the start date |
| The Overall Mortality Rate | The overall mortality rate was calculated by the incidence of all-cause death per observation time based on the person-year method (the number of deaths in 100 person-year). | 52 weeks from the start date |
| The Cardiovascular-related Mortality Rate | The cardiovascular-related mortality rate was calculated by the incidence of cardiovascular-related death per observation time based on the person-year method (the number of deaths in 100 person-year). Cardiovascular deaths were defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | 52 weeks from the start date |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Estimated creatinine clearance (eCLCr) | The Cockcroft & Gault formula was used to eCLCr. | Number | Participants |
|
| OG000 |
| Selara Tablets (Eplerenone) |
Participants who received Selara as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. |
|
|
| Secondary | Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician. | The safety analysis set comprised of chronic heart failure participants who satisfied the inclusion criteria and had received Selara at least once. | Posted | Number | Percentage of Participants | 52 weeks from the start date |
|
|
|
| Secondary | The Number of Deaths (Overall Deaths) | Overall deaths were described with the number of deaths from any cause at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | Posted | Number | Participants | 52 weeks from the start date |
|
|
|
| Secondary | The Number of Deaths (Cardiovascular Deaths) | Cardiovascular deaths were described with the number of deaths defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | Posted | Number | Participants | 52 weeks from the start date |
|
|
|
| Secondary | The Overall Mortality Rate | The overall mortality rate was calculated by the incidence of all-cause death per observation time based on the person-year method (the number of deaths in 100 person-year). | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | Posted | Number | 95% Confidence Interval | events per 100 patient-year | 52 weeks from the start date |
|
|
|
| Secondary | The Cardiovascular-related Mortality Rate | The cardiovascular-related mortality rate was calculated by the incidence of cardiovascular-related death per observation time based on the person-year method (the number of deaths in 100 person-year). Cardiovascular deaths were defined as any death due to cardiac failure, myocardial infarction, arrhythmia (atrial fibrillation, atrial flutter, arrhythmia supraventricular, or ventricular arrhythmia), stroke or cerebrovascular attack, and other causes related to cardiovascular system at the time of 52 weeks after the start of administration, regardless of the treatment status (completed or discontinued). | The efficacy analysis set comprised of chronic heart failure participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. | Posted | Number | 95% Confidence Interval | events per 100 patient-year | 52 weeks from the start date |
|
|
|
| 44 |
| 1,139 |
| 103 |
| 1,139 |
| 121 |
| 1,139 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Amyloidosis | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Infective spondylitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Coronary vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Mantle cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Postrenal failure | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Carotid artery aneurysm | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Nipple pain | Reproductive system and breast disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | 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.
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |