Trial Outcomes & Findings for Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) (NCT NCT03342690)
NCT ID: NCT03342690
Last Updated: 2023-07-11
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1165 participants
Primary outcome timeframe
52 weeks from the start date
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1164
|
|
Overall Study
COMPLETED
|
1139
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Missing Information
|
9
|
|
Overall Study
Protocol Violation
|
16
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Selara Tablets (Eplerenone)
n=1139 Participants
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.
|
|---|---|
|
Age, Customized
<15 years
|
0 Participants
n=1139 Participants
|
|
Age, Customized
≥15 and <65 years
|
219 Participants
n=1139 Participants
|
|
Age, Customized
≥65 years
|
920 Participants
n=1139 Participants
|
|
Sex: Female, Male
Female
|
516 Participants
n=1139 Participants
|
|
Sex: Female, Male
Male
|
623 Participants
n=1139 Participants
|
|
Estimated creatinine clearance (eCLCr)
<30 mL/min
|
92 Participants
n=1139 Participants
|
|
Estimated creatinine clearance (eCLCr)
≥30 mL/min and <50 mL/min
|
316 Participants
n=1139 Participants
|
|
Estimated creatinine clearance (eCLCr)
≥50 mL/min
|
524 Participants
n=1139 Participants
|
|
Estimated creatinine clearance (eCLCr)
Unknown
|
207 Participants
n=1139 Participants
|
PRIMARY outcome
Timeframe: 52 weeks from the start datePopulation: 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).
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.
Outcome measures
| Measure |
Selara Tablets (Eplerenone)
n=316 Participants
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.
|
|---|---|
|
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment
ADR
|
9.49 Percentage of Participants
|
|
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment
Serious ADR
|
1.58 Percentage of Participants
|
SECONDARY outcome
Timeframe: 52 weeks from the start datePopulation: The safety analysis set comprised of chronic heart failure participants who satisfied the inclusion criteria and had received Selara at least once.
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.
Outcome measures
| Measure |
Selara Tablets (Eplerenone)
n=1139 Participants
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.
|
|---|---|
|
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants
ADR
|
5.97 Percentage of Participants
|
|
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants
Serious ADR
|
0.79 Percentage of Participants
|
SECONDARY outcome
Timeframe: 52 weeks from the start datePopulation: 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.
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).
Outcome measures
| Measure |
Selara Tablets (Eplerenone)
n=1139 Participants
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.
|
|---|---|
|
The Number of Deaths (Overall Deaths)
|
44 Participants
|
SECONDARY outcome
Timeframe: 52 weeks from the start datePopulation: 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.
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).
Outcome measures
| Measure |
Selara Tablets (Eplerenone)
n=1139 Participants
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.
|
|---|---|
|
The Number of Deaths (Cardiovascular Deaths)
|
15 Participants
|
SECONDARY outcome
Timeframe: 52 weeks from the start datePopulation: 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.
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).
Outcome measures
| Measure |
Selara Tablets (Eplerenone)
n=1139 Participants
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.
|
|---|---|
|
The Overall Mortality Rate
|
4.4 events per 100 patient-year
Interval 3.2 to 6.0
|
SECONDARY outcome
Timeframe: 52 weeks from the start datePopulation: 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.
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).
Outcome measures
| Measure |
Selara Tablets (Eplerenone)
n=1139 Participants
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.
|
|---|---|
|
The Cardiovascular-related Mortality Rate
|
1.5 events per 100 patient-year
Interval 0.8 to 2.5
|
Adverse Events
Selara Tablets (Eplerenone)
Serious events: 103 serious events
Other events: 121 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Selara Tablets (Eplerenone)
n=1139 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.44%
5/1139 • 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.
|
|
Cardiac disorders
Right ventricular failure
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.18%
2/1139 • 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac failure acute
|
0.61%
7/1139 • 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.
|
|
Cardiac disorders
Angina pectoris
|
0.18%
2/1139 • 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.
|
|
Cardiac disorders
Bradycardia
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac tamponade
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.26%
3/1139 • 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.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.18%
2/1139 • 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.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
15/1139 • 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.
|
|
Cardiac disorders
Atrial flutter
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.26%
3/1139 • 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.
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Atrioventricular block
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.53%
6/1139 • 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.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.09%
1/1139 • 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.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.09%
1/1139 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.18%
2/1139 • 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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1139 • 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.
|
|
General disorders
Death
|
0.09%
1/1139 • 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.
|
|
General disorders
Hypothermia
|
0.18%
2/1139 • 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.
|
|
Immune system disorders
Amyloidosis
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Influenza
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Infective spondylitis
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Bacteraemia
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Diverticulitis
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Pneumonia
|
0.70%
8/1139 • 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.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Coronary vascular graft occlusion
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.18%
2/1139 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
2/1139 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1139 • 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.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.09%
1/1139 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.26%
3/1139 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
3/1139 • 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.18%
2/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma recurrent
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
1/1139 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Epilepsy
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
2/1139 • 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.
|
|
Nervous system disorders
Embolic stroke
|
0.18%
2/1139 • 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.
|
|
Nervous system disorders
Brain stem infarction
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.35%
4/1139 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
0.18%
2/1139 • 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.
|
|
Renal and urinary disorders
Postrenal failure
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.18%
2/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.26%
3/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.09%
1/1139 • 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.
|
|
Vascular disorders
Hypotension
|
0.09%
1/1139 • 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.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.09%
1/1139 • 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.
|
Other adverse events
| Measure |
Selara Tablets (Eplerenone)
n=1139 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.26%
3/1139 • 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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
2/1139 • 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.
|
|
Cardiac disorders
Bradycardia
|
0.09%
1/1139 • 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.
|
|
Cardiac disorders
Cardiac failure
|
0.35%
4/1139 • 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.
|
|
Cardiac disorders
Palpitations
|
0.09%
1/1139 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
1/1139 • 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.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
2/1139 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1139 • 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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.09%
1/1139 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.09%
1/1139 • 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.
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1139 • 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.
|
|
General disorders
Malaise
|
0.09%
1/1139 • 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.
|
|
General disorders
Oedema
|
0.26%
3/1139 • 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.
|
|
General disorders
Pyrexia
|
0.18%
2/1139 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.18%
2/1139 • 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.
|
|
Infections and infestations
Bronchitis
|
0.18%
2/1139 • 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.
|
|
Infections and infestations
Parotitis
|
0.09%
1/1139 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
2/1139 • 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.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.09%
1/1139 • 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.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.09%
1/1139 • 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.
|
|
Investigations
Blood creatinine increased
|
0.09%
1/1139 • 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.
|
|
Investigations
Blood potassium increased
|
0.35%
4/1139 • 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.
|
|
Investigations
Blood pressure decreased
|
0.79%
9/1139 • 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.
|
|
Investigations
Blood pressure increased
|
0.09%
1/1139 • 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.
|
|
Investigations
Blood urea increased
|
0.18%
2/1139 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.44%
5/1139 • 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
2/1139 • 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.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.09%
1/1139 • 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.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.09%
1/1139 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
16/1139 • 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.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.09%
1/1139 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.26%
3/1139 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.09%
1/1139 • 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.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Dizziness
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Hypoaesthesia
|
0.09%
1/1139 • 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.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Nocturia
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Pollakiuria
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Prerenal failure
|
0.09%
1/1139 • 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.
|
|
Renal and urinary disorders
Renal failure
|
0.26%
3/1139 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
2.1%
24/1139 • 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.
|
|
Renal and urinary disorders
Urge incontinence
|
0.09%
1/1139 • 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.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.18%
2/1139 • 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.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.18%
2/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
1/1139 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.09%
1/1139 • 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.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.18%
2/1139 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.09%
1/1139 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.09%
1/1139 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.09%
1/1139 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
1/1139 • 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.
|
|
Vascular disorders
Hypotension
|
0.88%
10/1139 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER