Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF (NCT NCT01870778)
NCT ID: NCT01870778
Last Updated: 2018-03-30
Results Overview
The percentage of participants with an adjudicated CV death through day 180 was assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6600 participants
Primary outcome timeframe
180 days
Results posted on
2018-03-30
Participant Flow
6600 participants were randomized into the trial. Only 6545 participants were eligible for analysis. Therefore, the participants flow and baseline characteristics are based on 6545 participants.
Participant milestones
| Measure |
Serelaxin (RLX030)
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
3274
|
3271
|
|
Overall Study
Safety Set
|
3257
|
3248
|
|
Overall Study
Full Analysis Set
|
3274
|
3271
|
|
Overall Study
Biomarker Analysis Set
|
521
|
510
|
|
Overall Study
COMPLETED
|
3266
|
3262
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Serelaxin (RLX030)
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
Baseline characteristics by cohort
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
Total
n=6545 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
72.8 Years
STANDARD_DEVIATION 11.17 • n=7 Participants
|
73.0 Years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1296 Participants
n=5 Participants
|
1341 Participants
n=7 Participants
|
2637 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1978 Participants
n=5 Participants
|
1930 Participants
n=7 Participants
|
3908 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
163 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3017 Participants
n=5 Participants
|
2999 Participants
n=7 Participants
|
6016 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
The percentage of participants with an adjudicated CV death through day 180 was assessed.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180
|
8.7 Percentage of participants
|
8.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 5Population: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
The percentage of participants with WHF through day 5 was assessed.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5
|
6.9 Percentage of participants
|
7.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
The percentage of participants with all-cause death through day 180 was assessed.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Percentage of Participants With All-cause Death Through Day 180
|
11.2 Percentage of participants
|
11.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 days (Participants still in the hospital at Day 60 were censored at Day 60)Population: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization
|
9.362 days
Standard Deviation 9.3581
|
9.545 days
Standard Deviation 9.6739
|
SECONDARY outcome
Timeframe: 180 daysPopulation: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization
|
24.3 Percentage of participants
|
24.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 days (Patients still in the hospital at Day 60 were censored at Day 60)Population: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.
Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3274 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3271 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
|
3.8 days
Standard Deviation 8.29
|
4.1 days
Standard Deviation 8.77
|
SECONDARY outcome
Timeframe: From baseline to Day 5Population: The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was considered for the analysis. For each symptom, only participants with observed baseline signs and symptoms and non-missing baseline and post baseline signs and symptoms were analyzed.
The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=3044 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3039 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Exertional dyspnea
|
94.1 Percentage of participants
|
92.6 Percentage of participants
|
|
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Orthopnea
|
92.9 Percentage of participants
|
91.2 Percentage of participants
|
|
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Rales
|
94.1 Percentage of participants
|
93.7 Percentage of participants
|
|
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Jugular venous pressure
|
90.4 Percentage of participants
|
88.0 Percentage of participants
|
|
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Peripheral edema, pre-sacral edema
|
91.6 Percentage of participants
|
90.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 5 and Day 14Population: Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.
Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=521 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=510 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Change From Baseline in hsTroponin T Biomarker
Day 2
|
0.9808 ug/L
Interval 0.9452 to 1.0177
|
1.0432 ug/L
Interval 1.0052 to 1.0827
|
|
Change From Baseline in hsTroponin T Biomarker
Day 5
|
0.9589 ug/L
Interval 0.9116 to 1.0087
|
1.0678 ug/L
Interval 1.0148 to 1.1237
|
|
Change From Baseline in hsTroponin T Biomarker
Day 14
|
0.7813 ug/L
Interval 0.7374 to 0.8278
|
0.8611 ug/L
Interval 0.8119 to 0.9132
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 5 and Day 14Population: Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.
Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=521 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=510 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Change From Baseline in NT-proBNP Biomarker
Day 2
|
0.4902 pg/mL
Interval 0.4609 to 0.5214
|
0.5702 pg/mL
Interval 0.5358 to 0.6068
|
|
Change From Baseline in NT-proBNP Biomarker
Day 5
|
0.4249 pg/mL
Interval 0.395 to 0.457
|
0.4454 pg/mL
Interval 0.4138 to 0.4794
|
|
Change From Baseline in NT-proBNP Biomarker
Day 14
|
0.4265 pg/mL
Interval 0.3957 to 0.4596
|
0.4469 pg/mL
Interval 0.4143 to 0.4822
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 5 and Day 14Population: Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.
Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.
Outcome measures
| Measure |
Serelaxin (RLX030)
n=521 Participants
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=510 Participants
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Change From Baseline in Cystatin C Biomarker
Day 2
|
1.0261 mg/L
Interval 1.0119 to 1.0406
|
1.0648 mg/L
Interval 1.0499 to 1.0799
|
|
Change From Baseline in Cystatin C Biomarker
Day 5
|
1.1171 mg/L
Interval 1.0976 to 1.1369
|
1.1259 mg/L
Interval 1.1061 to 1.1461
|
|
Change From Baseline in Cystatin C Biomarker
Day 14
|
1.1186 mg/L
Interval 1.0949 to 1.1429
|
1.1342 mg/L
Interval 1.1098 to 1.1591
|
Adverse Events
Serelaxin (RLX030)
Serious events: 412 serious events
Other events: 1336 other events
Deaths: 363 deaths
Placebo
Serious events: 424 serious events
Other events: 1277 other events
Deaths: 386 deaths
Serious adverse events
| Measure |
Serelaxin (RLX030)
n=3257 participants at risk
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3248 participants at risk
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.21%
7/3257 • up to 180 days
|
0.22%
7/3248 • up to 180 days
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
1/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Cardiac disorders
Acute left ventricular failure
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.43%
14/3257 • up to 180 days
|
0.37%
12/3248 • up to 180 days
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3257 • up to 180 days
|
0.22%
7/3248 • up to 180 days
|
|
Cardiac disorders
Angina unstable
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.12%
4/3257 • up to 180 days
|
0.28%
9/3248 • up to 180 days
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
10/3257 • up to 180 days
|
0.40%
13/3248 • up to 180 days
|
|
Cardiac disorders
Atrial flutter
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Atrioventricular block complete
|
0.15%
5/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Bradyarrhythmia
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Bradycardia
|
0.12%
4/3257 • up to 180 days
|
0.12%
4/3248 • up to 180 days
|
|
Cardiac disorders
Cardiac arrest
|
0.12%
4/3257 • up to 180 days
|
0.28%
9/3248 • up to 180 days
|
|
Cardiac disorders
Cardiac failure
|
1.9%
62/3257 • up to 180 days
|
2.1%
68/3248 • up to 180 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.43%
14/3257 • up to 180 days
|
0.25%
8/3248 • up to 180 days
|
|
Cardiac disorders
Cardiac failure chronic
|
0.06%
2/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.37%
12/3257 • up to 180 days
|
0.28%
9/3248 • up to 180 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.15%
5/3257 • up to 180 days
|
0.18%
6/3248 • up to 180 days
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.06%
2/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Coronary artery disease
|
0.52%
17/3257 • up to 180 days
|
0.37%
12/3248 • up to 180 days
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Coronary artery perforation
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.15%
5/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Mitral valve incompetence
|
0.15%
5/3257 • up to 180 days
|
0.15%
5/3248 • up to 180 days
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
3/3257 • up to 180 days
|
0.12%
4/3248 • up to 180 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
2/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Tachycardia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Torsade de pointes
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Cardiac disorders
Ventricular fibrillation
|
0.12%
4/3257 • up to 180 days
|
0.18%
6/3248 • up to 180 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.43%
14/3257 • up to 180 days
|
0.34%
11/3248 • up to 180 days
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Ileus
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
General disorders
Asthenia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
Cardiac death
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
General disorders
Drug effect increased
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
General disorders
Extravasation
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
Fatigue
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
General physical health deterioration
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
General disorders
Inflammation
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.12%
4/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
Non-cardiac chest pain
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
General disorders
Pyrexia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
Sudden cardiac death
|
0.09%
3/3257 • up to 180 days
|
0.18%
6/3248 • up to 180 days
|
|
General disorders
Sudden death
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Hepatobiliary disorders
Hepatic failure
|
0.06%
2/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.06%
2/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Hepatobiliary disorders
Liver injury
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Abdominal abscess
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Arthritis bacterial
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Aspergilloma
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Bronchitis
|
0.28%
9/3257 • up to 180 days
|
0.12%
4/3248 • up to 180 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Cholecystitis infective
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Chronic hepatitis B
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Cystitis
|
0.09%
3/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Erysipelas
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Gastroenteritis
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Influenza
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Nosocomial infection
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Orchitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Pneumococcal sepsis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Pneumonia
|
1.0%
34/3257 • up to 180 days
|
0.99%
32/3248 • up to 180 days
|
|
Infections and infestations
Pneumonia streptococcal
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Pulmonary sepsis
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Sepsis
|
0.18%
6/3257 • up to 180 days
|
0.25%
8/3248 • up to 180 days
|
|
Infections and infestations
Septic shock
|
0.12%
4/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.06%
2/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Streptococcal sepsis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Infections and infestations
Urinary tract infection
|
0.40%
13/3257 • up to 180 days
|
0.15%
5/3248 • up to 180 days
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Infections and infestations
Urosepsis
|
0.03%
1/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Aortic restenosis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.06%
2/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Investigations
Blood bilirubin increased
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Investigations
Blood pressure decreased
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Investigations
C-reactive protein increased
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Investigations
Cardiac output decreased
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Investigations
Ejection fraction decreased
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Investigations
Hepatic enzyme increased
|
0.09%
3/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Investigations
Liver function test increased
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Investigations
Oxygen saturation decreased
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Investigations
Troponin increased
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Investigations
Vascular resistance pulmonary increased
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
3/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.09%
3/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Aphasia
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
2/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Dementia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Embolic stroke
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Hypercapnic coma
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.34%
11/3257 • up to 180 days
|
0.49%
16/3248 • up to 180 days
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Presyncope
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Radiculopathy
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Seizure
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Nervous system disorders
Somnolence
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Syncope
|
0.15%
5/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
6/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Nervous system disorders
Vascular encephalopathy
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Product Issues
Device battery issue
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Product Issues
Device leakage
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Product Issues
Device malfunction
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Psychiatric disorders
Confusional state
|
0.06%
2/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Psychiatric disorders
Delirium
|
0.06%
2/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Psychiatric disorders
Delirium tremens
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
20/3257 • up to 180 days
|
0.77%
25/3248 • up to 180 days
|
|
Renal and urinary disorders
Anuria
|
0.06%
2/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Renal and urinary disorders
Azotaemia
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.12%
4/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Renal and urinary disorders
Haematuria
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/3257 • up to 180 days
|
0.18%
6/3248 • up to 180 days
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Renal and urinary disorders
Oliguria
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Renal and urinary disorders
Prerenal failure
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Renal and urinary disorders
Renal failure
|
0.31%
10/3257 • up to 180 days
|
0.49%
16/3248 • up to 180 days
|
|
Renal and urinary disorders
Renal impairment
|
0.40%
13/3257 • up to 180 days
|
0.28%
9/3248 • up to 180 days
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Renal and urinary disorders
Urinary retention
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.15%
5/3257 • up to 180 days
|
0.15%
5/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.09%
3/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.15%
5/3257 • up to 180 days
|
0.22%
7/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.18%
6/3257 • up to 180 days
|
0.15%
5/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
5/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
5/3257 • up to 180 days
|
0.22%
7/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.03%
1/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
3/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.21%
7/3257 • up to 180 days
|
0.31%
10/3248 • up to 180 days
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Surgical and medical procedures
Cardioversion
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/3257 • up to 180 days
|
0.06%
2/3248 • up to 180 days
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Hypertension
|
0.03%
1/3257 • up to 180 days
|
0.09%
3/3248 • up to 180 days
|
|
Vascular disorders
Hypertensive crisis
|
0.09%
3/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Hypotension
|
0.43%
14/3257 • up to 180 days
|
0.28%
9/3248 • up to 180 days
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Iliac artery embolism
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
|
Vascular disorders
Shock
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Vascular disorders
Subclavian steal syndrome
|
0.03%
1/3257 • up to 180 days
|
0.00%
0/3248 • up to 180 days
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3257 • up to 180 days
|
0.03%
1/3248 • up to 180 days
|
Other adverse events
| Measure |
Serelaxin (RLX030)
n=3257 participants at risk
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
|
Placebo
n=3248 participants at risk
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
48/3257 • up to 180 days
|
1.4%
47/3248 • up to 180 days
|
|
Cardiac disorders
Angina pectoris
|
0.52%
17/3257 • up to 180 days
|
0.46%
15/3248 • up to 180 days
|
|
Cardiac disorders
Aortic valve incompetence
|
0.64%
21/3257 • up to 180 days
|
0.77%
25/3248 • up to 180 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.71%
23/3257 • up to 180 days
|
0.40%
13/3248 • up to 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
46/3257 • up to 180 days
|
1.4%
45/3248 • up to 180 days
|
|
Cardiac disorders
Bradycardia
|
0.71%
23/3257 • up to 180 days
|
0.68%
22/3248 • up to 180 days
|
|
Cardiac disorders
Cardiac failure
|
5.0%
162/3257 • up to 180 days
|
5.7%
185/3248 • up to 180 days
|
|
Cardiac disorders
Mitral valve incompetence
|
1.6%
52/3257 • up to 180 days
|
1.4%
47/3248 • up to 180 days
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.92%
30/3257 • up to 180 days
|
0.65%
21/3248 • up to 180 days
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
37/3257 • up to 180 days
|
0.74%
24/3248 • up to 180 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.55%
18/3257 • up to 180 days
|
0.58%
19/3248 • up to 180 days
|
|
Gastrointestinal disorders
Constipation
|
2.1%
70/3257 • up to 180 days
|
1.8%
57/3248 • up to 180 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
44/3257 • up to 180 days
|
1.6%
52/3248 • up to 180 days
|
|
Gastrointestinal disorders
Nausea
|
1.8%
59/3257 • up to 180 days
|
1.6%
51/3248 • up to 180 days
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
30/3257 • up to 180 days
|
0.74%
24/3248 • up to 180 days
|
|
General disorders
Non-cardiac chest pain
|
0.37%
12/3257 • up to 180 days
|
0.62%
20/3248 • up to 180 days
|
|
General disorders
Pyrexia
|
0.95%
31/3257 • up to 180 days
|
1.3%
41/3248 • up to 180 days
|
|
Infections and infestations
Bronchitis
|
0.92%
30/3257 • up to 180 days
|
1.4%
47/3248 • up to 180 days
|
|
Infections and infestations
Cystitis
|
0.55%
18/3257 • up to 180 days
|
0.22%
7/3248 • up to 180 days
|
|
Infections and infestations
Pneumonia
|
0.52%
17/3257 • up to 180 days
|
0.68%
22/3248 • up to 180 days
|
|
Infections and infestations
Urinary tract infection
|
1.8%
58/3257 • up to 180 days
|
2.1%
68/3248 • up to 180 days
|
|
Investigations
Blood creatinine increased
|
1.1%
36/3257 • up to 180 days
|
1.5%
49/3248 • up to 180 days
|
|
Investigations
Blood potassium decreased
|
0.46%
15/3257 • up to 180 days
|
0.62%
20/3248 • up to 180 days
|
|
Investigations
Blood pressure decreased
|
1.1%
36/3257 • up to 180 days
|
0.71%
23/3248 • up to 180 days
|
|
Investigations
Blood pressure systolic decreased
|
0.89%
29/3257 • up to 180 days
|
0.74%
24/3248 • up to 180 days
|
|
Investigations
Blood urea increased
|
0.74%
24/3257 • up to 180 days
|
0.77%
25/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Gout
|
0.49%
16/3257 • up to 180 days
|
0.86%
28/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.77%
25/3257 • up to 180 days
|
0.52%
17/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
40/3257 • up to 180 days
|
1.1%
36/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.77%
25/3257 • up to 180 days
|
0.65%
21/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.89%
29/3257 • up to 180 days
|
0.68%
22/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
263/3257 • up to 180 days
|
7.4%
241/3248 • up to 180 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
19/3257 • up to 180 days
|
0.40%
13/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.77%
25/3257 • up to 180 days
|
0.65%
21/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
22/3257 • up to 180 days
|
0.80%
26/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
79/3257 • up to 180 days
|
1.5%
49/3248 • up to 180 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.83%
27/3257 • up to 180 days
|
0.99%
32/3248 • up to 180 days
|
|
Nervous system disorders
Dizziness
|
0.83%
27/3257 • up to 180 days
|
0.52%
17/3248 • up to 180 days
|
|
Nervous system disorders
Headache
|
2.3%
74/3257 • up to 180 days
|
2.8%
92/3248 • up to 180 days
|
|
Psychiatric disorders
Anxiety
|
0.49%
16/3257 • up to 180 days
|
0.92%
30/3248 • up to 180 days
|
|
Psychiatric disorders
Confusional state
|
0.77%
25/3257 • up to 180 days
|
0.86%
28/3248 • up to 180 days
|
|
Psychiatric disorders
Insomnia
|
1.3%
42/3257 • up to 180 days
|
1.5%
48/3248 • up to 180 days
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
35/3257 • up to 180 days
|
1.0%
34/3248 • up to 180 days
|
|
Renal and urinary disorders
Haematuria
|
0.61%
20/3257 • up to 180 days
|
0.62%
20/3248 • up to 180 days
|
|
Renal and urinary disorders
Renal failure
|
1.3%
42/3257 • up to 180 days
|
1.4%
46/3248 • up to 180 days
|
|
Renal and urinary disorders
Renal impairment
|
1.5%
48/3257 • up to 180 days
|
1.7%
55/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
6/3257 • up to 180 days
|
0.52%
17/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
41/3257 • up to 180 days
|
1.1%
36/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.52%
17/3257 • up to 180 days
|
0.46%
15/3248 • up to 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.58%
19/3257 • up to 180 days
|
0.43%
14/3248 • up to 180 days
|
|
Vascular disorders
Hypertension
|
0.71%
23/3257 • up to 180 days
|
1.1%
37/3248 • up to 180 days
|
|
Vascular disorders
Hypotension
|
2.1%
69/3257 • up to 180 days
|
1.8%
58/3248 • up to 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER