Trial Outcomes & Findings for Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE] (NCT NCT03265145)
NCT ID: NCT03265145
Last Updated: 2022-06-14
Results Overview
Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
714 participants
Primary outcome timeframe
Baseline till end of study, up to 12 months.
Results posted on
2022-06-14
Participant Flow
This was a pragmatic randomized open label active controlled parallel group design trial conducted in a real-world, community-based practice setting. Participants were on long-acting muscarinic antagonist (LAMA), long-acting beta agonist (LABA) or Inhaled Corticosteroid (ICS)/LABA for COPD, but were determined by their physician to not be controlled on their current therapy. Subjects were randomized to either Stiolto Respimat or ICS plus LABA plus LAMA (triple therapy) for the study.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Stiolto® Respimat®
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
356
|
358
|
|
Overall Study
COMPLETED
|
285
|
302
|
|
Overall Study
NOT COMPLETED
|
71
|
56
|
Reasons for withdrawal
| Measure |
Stiolto® Respimat®
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
23
|
19
|
|
Overall Study
Death
|
12
|
12
|
|
Overall Study
Lost to Follow-up
|
13
|
9
|
|
Overall Study
missing end of study form, could not definitely count as completion or discontinuation
|
0
|
1
|
|
Overall Study
Switched back to previous medication
|
1
|
0
|
|
Overall Study
Did not want to take medication
|
1
|
0
|
|
Overall Study
Subject could not afford medication
|
0
|
1
|
|
Overall Study
Site closed
|
2
|
3
|
|
Overall Study
Incorrectly randomized
|
16
|
6
|
|
Overall Study
Entered into Electronic Data Capture in error
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Subject transferred to another facility
|
0
|
1
|
Baseline Characteristics
Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]
Baseline characteristics by cohort
| Measure |
Stiolto® Respimat®
n=356 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=358 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
Total
n=714 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 9.32 • n=99 Participants
|
69.9 years
STANDARD_DEVIATION 9.81 • n=107 Participants
|
69.5 years
STANDARD_DEVIATION 9.57 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
181 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
169 Participants
n=99 Participants
|
181 Participants
n=107 Participants
|
350 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Missing
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
329 Participants
n=99 Participants
|
334 Participants
n=107 Participants
|
663 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
292 Participants
n=99 Participants
|
300 Participants
n=107 Participants
|
592 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline till end of study, up to 12 months.Population: Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment.
Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves.
Outcome measures
| Measure |
Stiolto® Respimat®
n=348 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=354 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period
|
NA Months
Non-calculable as the median was not reached (and neither was the Q1).
|
NA Months
Non-calculable as the median was not reached (and neither was the Q1).
|
SECONDARY outcome
Timeframe: Baseline till end of study, up to 12 months.Population: Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment.
Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate.
Outcome measures
| Measure |
Stiolto® Respimat®
n=348 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=354 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
|
0.36 Exacerbations per participant per year
Interval 0.28 to 0.47
|
0.26 Exacerbations per participant per year
Interval 0.19 to 0.34
|
SECONDARY outcome
Timeframe: Baseline till end of study, up to 12 months.Population: Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment.
Time to first severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves.
Outcome measures
| Measure |
Stiolto® Respimat®
n=348 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=354 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease
|
NA Months
Non-calculable as the median was not reached (and neither was the Q1).
|
NA Months
Non-calculable as the median was not reached (and neither was the Q1).
|
SECONDARY outcome
Timeframe: Baseline till end of study, up to 12 months.Population: Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment.
Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate.
Outcome measures
| Measure |
Stiolto® Respimat®
n=348 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=354 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
|
0.07 Exacerbations per participant per year
Interval 0.04 to 0.12
|
0.07 Exacerbations per participant per year
Interval 0.04 to 0.11
|
SECONDARY outcome
Timeframe: 12 months after baseline.Population: Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment.
Number of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations over the 12 month observation period. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1).
Outcome measures
| Measure |
Stiolto® Respimat®
n=348 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=354 Participants
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period
|
73 Participants
|
62 Participants
|
Adverse Events
Stiolto® Respimat®
Serious events: 56 serious events
Other events: 0 other events
Deaths: 12 deaths
ICS Plus LABA Plus LAMA (Triple Therapy)
Serious events: 45 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Stiolto® Respimat®
n=325 participants at risk
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
ICS Plus LABA Plus LAMA (Triple Therapy)
n=318 participants at risk
Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician.
Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment.
|
|---|---|---|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Cardiac arrest
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Cardiac failure
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.94%
3/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Cardiac failure acute
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Coronary artery disease
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Left ventricular failure
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Tachycardia
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Gastrointestinal disorders
Melaena
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
General disorders
Asthenia
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
General disorders
Chest pain
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
General disorders
Death
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
General disorders
Generalised oedema
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
General disorders
Malaise
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Bacteraemia
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Bronchitis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Cellulitis
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Escherichia sepsis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.2%
4/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Influenza
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Pneumonia
|
1.8%
6/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
2.8%
9/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Sepsis
|
1.2%
4/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.94%
3/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Septic shock
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Urinary tract infection
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
Urinary tract infection viral
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Injury, poisoning and procedural complications
Fall
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Investigations
Blood osmolarity decreased
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Investigations
Blood pressure increased
|
1.5%
5/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Investigations
Heart rate increased
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Investigations
Troponin increased
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Dizziness
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Encephalopathy
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Headache
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Syncope
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Psychiatric disorders
Delirium
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Psychiatric disorders
Mental status changes
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Renal and urinary disorders
Renal disorder
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.62%
2/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
2.2%
7/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
20/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
6.0%
19/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
4/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.92%
3/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.63%
2/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Surgical and medical procedures
Transcatheter aortic valve implantation
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Vascular disorders
Aortic stenosis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Vascular disorders
Arteriosclerosis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Vascular disorders
Deep vein thrombosis
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Vascular disorders
Hypertension
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Infections and infestations
COVID-19
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.31%
1/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.31%
1/325 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
0.00%
0/318 • Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment. Adverse events (AE): all randomized patients who received a prescription of any study treatment. Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER