Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control (NCT NCT00393458)
NCT ID: NCT00393458
Last Updated: 2011-08-18
Results Overview
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1732 participants
Primary outcome timeframe
Week 12 + 1 day, Day 85
Results posted on
2011-08-18
Participant Flow
Participant milestones
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
437
|
428
|
435
|
432
|
|
Overall Study
Exposed to Study Medication or Placebo
|
437
|
425
|
434
|
432
|
|
Overall Study
COMPLETED
|
338
|
326
|
323
|
295
|
|
Overall Study
NOT COMPLETED
|
99
|
102
|
112
|
137
|
Reasons for withdrawal
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
35
|
24
|
40
|
35
|
|
Overall Study
Subject withdrew consent
|
27
|
40
|
33
|
50
|
|
Overall Study
Unsatisfactory therapeutic effect
|
12
|
9
|
12
|
30
|
|
Overall Study
Protocol deviation
|
11
|
11
|
11
|
10
|
|
Overall Study
Administrative problems
|
7
|
8
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
5
|
3
|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
5
|
5
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
1
|
1
|
2
|
|
Overall Study
Subject no longer requires study drug
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
Baseline characteristics by cohort
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
n=437 Participants
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
n=425 Participants
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
n=434 Participants
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
n=432 Participants
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Total
n=1728 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
63.9 years
STANDARD_DEVIATION 8.57 • n=99 Participants
|
62.9 years
STANDARD_DEVIATION 8.74 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 8.49 • n=206 Participants
|
63.2 years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 8.52 • n=31 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
350 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
351 Participants
n=99 Participants
|
327 Participants
n=107 Participants
|
348 Participants
n=206 Participants
|
352 Participants
n=7 Participants
|
1378 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 12 + 1 day, Day 85Population: Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
n=389 Participants
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
n=374 Participants
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
n=379 Participants
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
n=371 Participants
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
|
1.48 Liters
Standard Error 0.012
|
1.48 Liters
Standard Error 0.013
|
1.38 Liters
Standard Error 0.013
|
1.31 Liters
Standard Error 0.013
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 52)Population: Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
n=386 Participants
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
n=370 Participants
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
n=377 Participants
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
n=366 Participants
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Percentage of Days of Poor Control During 52 Weeks of Treatment
|
33.6 Percentage of days
Standard Error 1.43
|
30.0 Percentage of days
Standard Error 1.46
|
33.5 Percentage of days
Standard Error 1.45
|
38.3 Percentage of days
Standard Error 1.47
|
Adverse Events
Indacaterol 300 μg Plus Placebo to Formoterol
Serious events: 63 serious events
Other events: 199 other events
Deaths: 0 deaths
Indacaterol 600 μg Plus Placebo to Formoterol
Serious events: 51 serious events
Other events: 183 other events
Deaths: 0 deaths
Formoterol 12 μg Plus Placebo to Indacaterol
Serious events: 69 serious events
Other events: 164 other events
Deaths: 0 deaths
Placebo to Indacaterol Plus Placebo to Formoterol
Serious events: 48 serious events
Other events: 176 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
n=437 participants at risk
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
n=425 participants at risk
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
n=434 participants at risk
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
n=432 participants at risk
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
General disorders
Chest pain
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
General disorders
Hyperthermia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
General disorders
Sudden death
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.69%
3/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Atrial fibrillation
|
0.69%
3/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Cardiac failure
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.71%
3/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Microvascular angina
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.47%
2/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Palpitations
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Sinus arrhythmia
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Eye disorders
Anterior capsule contraction
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Eye disorders
Cataract
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Eye disorders
Macular degeneration
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Femoral hernia
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Appendicitis
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Erysipelas
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.47%
2/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
1.2%
5/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.69%
3/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Pneumonia
|
0.69%
3/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.47%
2/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
1.2%
5/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Pyothorax
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Septic shock
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.69%
3/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.92%
4/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
1.2%
5/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.93%
4/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Viral infection
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.47%
2/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Investigations
Blood creatine increased
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Investigations
Blood urea increased
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Investigations
Colonoscopy
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Brain injury
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Facial palsy
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Presyncope
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Syncope
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Psychiatric disorders
Depression
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Renal and urinary disorders
Renal failure acute
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.1%
18/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
2.8%
12/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
7.4%
32/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
4.6%
20/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
3/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
1/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.69%
3/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
1.2%
5/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Aortic aneurysm
|
0.46%
2/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Hypertension
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.46%
2/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.24%
1/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Vascular disorders
Shock
|
0.00%
0/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.23%
1/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
0.00%
0/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
Other adverse events
| Measure |
Indacaterol 300 μg Plus Placebo to Formoterol
n=437 participants at risk
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg Plus Placebo to Formoterol
n=425 participants at risk
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Formoterol 12 μg Plus Placebo to Indacaterol
n=434 participants at risk
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Placebo to Indacaterol Plus Placebo to Formoterol
n=432 participants at risk
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
5.7%
25/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
4.9%
21/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
3.9%
17/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
4.6%
20/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
73/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
18.8%
80/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
14.3%
62/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
13.0%
56/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
5.9%
26/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
5.9%
25/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
4.6%
20/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
7.6%
33/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
23/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
5.9%
25/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
2.8%
12/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
1.4%
6/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
29.3%
128/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
25.4%
108/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
25.8%
112/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
31.9%
138/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
32/437 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
6.4%
27/425 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
3.9%
17/434 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
4.4%
19/432 • Safety population: All patients who received at least 1 dose of study drug.
Baseline to the end of the study (Week 52)
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER