Trial Outcomes & Findings for Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone (NCT NCT00391846)

NCT ID: NCT00391846

Last Updated: 2012-06-25

Results Overview

The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 252 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2012-06-25

Participant Flow

This was a randomised, parallel group, single blind, multicentre, 9-month study in chronic heart failure in patients with New York Heart Association classification of heart failure (NYHA) class II-IV, left ventricular systolic dysfunction and elevated NT-proBNP levels in the primary care setting.

At visit 1 was the NT-proBNP value measured at this value should be above 800 (females) or 1000 (males) before randomisation at visit 2. One patient from each group are excluded from the full analysis set (FAS) due to "total unavailability of efficacy data after randomisation".

Participant milestones

Measure	Guided by NT-proBNP Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP Chronic heart failure treatment guided by clinical symptoms and signs
Overall Study STARTED	127	125
Overall Study COMPLETED	119	118
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Measure	Guided by NT-proBNP Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP Chronic heart failure treatment guided by clinical symptoms and signs
Overall Study Adverse Event	4	1
Overall Study Did not meet the required elig. crit	2	2
Overall Study Withdrawal by Subject	2	3
Overall Study Developed study specific DC criteria	0	1

Baseline Characteristics

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Baseline characteristics by cohort

Measure	Guided by NT-proBNP n=127 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=125 Participants Chronic heart failure treatment guided by clinical symptoms and signs	Total n=252 Participants Total of all reporting groups
Age Continuous	78 Years n=5 Participants	77 Years n=7 Participants	77 Years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	42 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	83 Participants n=7 Participants	180 Participants n=5 Participants
Electrocardiogram (ECG), Abnormal/Normal Abnormal ECG	115 Participants n=5 Participants	113 Participants n=7 Participants	228 Participants n=5 Participants
Electrocardiogram (ECG), Abnormal/Normal Normal ECG	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Diastolic blood pressure	73 mmHg STANDARD_DEVIATION 11 • n=5 Participants	75 mmHg STANDARD_DEVIATION 12 • n=7 Participants	74 mmHg STANDARD_DEVIATION 11 • n=5 Participants
Pulse	71 Beats/minute STANDARD_DEVIATION 14 • n=5 Participants	72 Beats/minute STANDARD_DEVIATION 14 • n=7 Participants	72 Beats/minute STANDARD_DEVIATION 14 • n=5 Participants
Systolic blood pressure	133 mmHg STANDARD_DEVIATION 21 • n=5 Participants	135 mmHg STANDARD_DEVIATION 22 • n=7 Participants	134 mmHg STANDARD_DEVIATION 21 • n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)	118.6 Scores on a scale Standard Deviation 558	128.4 Scores on a scale Standard Deviation 558

SECONDARY outcome

Timeframe: 9 months

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

Number of deaths

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Number of CV Deaths	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 9 months

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

Each overnight stay is counted as one day. The lower the better

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Number of Days in Hospital for CV Reason	5.79 Days in hospital Standard Deviation 6.63	5.94 Days in hospital Standard Deviation 6.32

SECONDARY outcome

Timeframe: 9 months and baseline

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Changes in Heart Failure Symptoms	3.67 Categorial scale Standard Deviation 20.02	6.11 Categorial scale Standard Deviation 21.00

SECONDARY outcome

Timeframe: 9 months and baseline

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

The 95% confidential interval (CI) is given as measure of dispersion

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Changes in NT-proBNP Values Over Time in All Patients	2332.1 ng/L Interval 1986.1 to 2738.4	2063 ng/L Interval 1743.2 to 2442.7

SECONDARY outcome

Timeframe: 9 months and baseline

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

Change range -100 to 100. The higher the better.

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Changes in Health-related Quality of Life	1.739 KCCQ overall score Standard Error 1.39	3.172 KCCQ overall score Standard Error 1.39

SECONDARY outcome

Timeframe: 9 months

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.

Outcome measures

Measure	Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=123 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Total Number of Titration Steps in Prescribed Heart Failure Treatment	517 Titration steps	485 Titration steps

SECONDARY outcome

Timeframe: 9 months

Population: In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol.

Number of patients discontinued due to adverse events'

Outcome measures

Measure	Guided by NT-proBNP n=127 Participants Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=125 Participants Chronic heart failure treatment guided by clinical symptoms and signs
Discontinuations	8 Participants	6 Participants

Adverse Events

Guided by NT-proBNP

Serious events: 46 serious events

Other events: 0 other events

Deaths: 0 deaths

Not Guided by NT-proBNP

Serious events: 41 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Guided by NT-proBNP n=127 participants at risk Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP	Not Guided by NT-proBNP n=125 participants at risk Chronic heart failure treatment guided by clinical symptoms and signs
Cardiac disorders Acute Myocardial Infarction	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Blood and lymphatic system disorders Anaemia	1.6% 2/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Angina Pectoris	1.6% 2/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Angina Unstable	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Aortic Aneurysm	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Aortic Stenosis	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Artial Fibrillation	1.6% 2/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	2.4% 3/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Atrioventricular Block Complete	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Blood and lymphatic system disorders B-Cell Lymphoma	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Back Pain	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Bleeding Varicose Vein	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Injury, poisoning and procedural complications Blood Electrolytes Abnormal	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Injury, poisoning and procedural complications Blood Pressure Decreased	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Bradycardia	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Bronchitis	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Renal and urinary disorders Calculus Ureathral	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Cardiac Failure	9.4% 12/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	5.6% 7/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Carotid Artery Stenosis	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Nervous system disorders Cerebral Infarction	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Nervous system disorders Cerebrovascular Accident	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Chest Pain	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Blood and lymphatic system disorders Chronic Lymphocytic Leukaemia	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	2.4% 3/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Injury, poisoning and procedural complications Concussion	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Psychiatric disorders Confusional State	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Death	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Metabolism and nutrition disorders Dehydration	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Diarrhoea	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Diverticulitis	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Dyspepsia	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 3/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Endocarditis	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Fatigue	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Femur Fracture	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Gastrointestinal Tract Adenoma	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Haematemesis	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Headache	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Heamorrhage	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Renal and urinary disorders Hepatic Failure	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Hip Fracture	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Metabolism and nutrition disorders Hyperkalaemia	1.6% 2/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Hypertension	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Intermittent Claudication	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Intervertebral Disc Compression	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Gastrointestinal disorders Intestinal Ischaemia	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Metabolism and nutrition disorders Malnutrition	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Multi-Organ Failure	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Muscular Weakness	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Myocardial Infarction	3.9% 5/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	4.8% 6/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Odema Peripheral	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Osteoporotic Fracture	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Peripheral Embolism	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Peripheral Ischaemia	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Pneumonia	1.6% 2/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	3.2% 4/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Pulmonary Odema	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Renal and urinary disorders Pyelonephritis	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Pyrexia	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Renal and urinary disorders Renal Failure	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	1.6% 2/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Infection Viral	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Rib Fracture	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Right Ventricular Failure	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Septic Shock	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Sick Sinus Syndrome	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Sepsis	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Musculoskeletal and connective tissue disorders Spinal Fracture	0.79% 1/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.00% 0/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Nervous system disorders Syncope	2.4% 3/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Injury, poisoning and procedural complications Therapeutic Agent Toxicity	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Urosepis	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Vascular disorders Venous Thrombosis Limb	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Cardiac disorders Ventricular Tachycardia	1.6% 2/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
General disorders Vertigo	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.
Infections and infestations Herpes Zoster	0.00% 0/127 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.	0.80% 1/125 Only Serious Adverse Event were to be reported. Other Adverse Events (Non-Serious Adverse Events) were to be reported by investigators directly to MPA (Medical Product Agency) in accordance to local legislation.

Other adverse events

Adverse event data not reported

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER