Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01437397)
NCT ID: NCT01437397
Last Updated: 2017-03-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1692 participants
Primary outcome timeframe
Week 24 of treatment
Results posted on
2017-03-23
Participant Flow
This study was conducted at 205 sites, 178 in the United States, 9 in Canada, 10 in Australia, and 8 in New Zealand. The first patient was screened in October 2011 and the last patient visit was in February 2013
A total of 3260 patients were screened for eligibility; 1692 patients were randomized to treatment. A total of 1568 (48.1%) patients screen failed and were discontinued prior to randomization. The primary reason for screening failures was not meeting inclusion/exclusion criteria (41.6%)
Participant milestones
| Measure |
Aclidinium/Formoterol 400/12 μg
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
Administered BID by inhalation
|
Formoterol 12 μg
Administered BID by inhalation
|
Placebo
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
338
|
338
|
340
|
339
|
337
|
|
Overall Study
COMPLETED
|
272
|
276
|
268
|
270
|
236
|
|
Overall Study
NOT COMPLETED
|
66
|
62
|
72
|
69
|
101
|
Reasons for withdrawal
| Measure |
Aclidinium/Formoterol 400/12 μg
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
Administered BID by inhalation
|
Formoterol 12 μg
Administered BID by inhalation
|
Placebo
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
2
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
12
|
24
|
11
|
22
|
|
Overall Study
Protocol Violation
|
10
|
12
|
13
|
21
|
19
|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
8
|
10
|
20
|
|
Overall Study
Adverse Event
|
21
|
22
|
16
|
14
|
21
|
|
Overall Study
Site termination/COPD exacerbation/other
|
10
|
8
|
9
|
9
|
14
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 Participants
Administered BID by inhalation
|
Formoterol 12 μg
n=332 Participants
Administered BID by inhalation
|
Placebo
n=332 Participants
Administered BID by inhalation
|
Total
n=1669 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
63.9 Years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
64.4 Years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
63.7 Years
STANDARD_DEVIATION 8.7 • n=483 Participants
|
63.5 Years
STANDARD_DEVIATION 8.9 • n=36 Participants
|
63.9 Years
STANDARD_DEVIATION 8.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
163 Participants
n=483 Participants
|
157 Participants
n=36 Participants
|
782 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=93 Participants
|
187 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
169 Participants
n=483 Participants
|
175 Participants
n=36 Participants
|
887 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 24 of treatmentPopulation: ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment
Outcome measures
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 Participants
Administered BID by inhalation
|
Formoterol 12 μg
n=332 Participants
Administered BID by inhalation
|
Placebo
n=331 Participants
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)
|
0.247 Liters
Standard Error 0.013
|
0.226 Liters
Standard Error 0.013
|
0.139 Liters
Standard Error 0.013
|
0.165 Liters
Standard Error 0.013
|
-0.037 Liters
Standard Error 0.014
|
PRIMARY outcome
Timeframe: Week 24 of treatmentPopulation: ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment
Outcome measures
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 Participants
Administered BID by inhalation
|
Formoterol 12 μg
n=332 Participants
Administered BID by inhalation
|
Placebo
n=331 Participants
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1)
|
0.095 Liters
Standard Error 0.012
|
0.076 Liters
Standard Error 0.012
|
0.066 Liters
Standard Error 0.012
|
0.050 Liters
Standard Error 0.012
|
-0.035 Liters
Standard Error 0.013
|
SECONDARY outcome
Timeframe: Week 24 of treatmentPopulation: ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment
The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort).TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.
Outcome measures
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 Participants
Administered BID by inhalation
|
Formoterol 12 μg
n=332 Participants
Administered BID by inhalation
|
Placebo
n=331 Participants
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Change in Transition Dyspnea Index (TDI) Focal Score
|
2.017 Scores on a scale
Standard Error 0.203
|
1.977 Scores on a scale
Standard Error 0.199
|
1.558 Scores on a scale
Standard Error 0.201
|
1.522 Scores on a scale
Standard Error 0.201
|
0.582 Scores on a scale
Standard Error 0.216
|
SECONDARY outcome
Timeframe: Week 24 of treatmentPopulation: ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment
St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 2 parts with 3 dimension scores (a symptom score and an activity and impacts score). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).
Outcome measures
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 Participants
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 Participants
Administered BID by inhalation
|
Formoterol 12 μg
n=332 Participants
Administered BID by inhalation
|
Placebo
n=331 Participants
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
|
-6.568 Scores on a scale
Standard Error 0.740
|
-5.942 Scores on a scale
Standard Error 0.728
|
-6.438 Scores on a scale
Standard Error 0.738
|
-4.701 Scores on a scale
Standard Error 0.742
|
-2.215 Scores on a scale
Standard Error 0.779
|
Adverse Events
Aclidinium/Formoterol 400/12 μg
Serious events: 19 serious events
Other events: 63 other events
Deaths: 0 deaths
Aclidinium/Formoterol 400/6 μg
Serious events: 18 serious events
Other events: 65 other events
Deaths: 0 deaths
Aclidinium 400 μg
Serious events: 17 serious events
Other events: 57 other events
Deaths: 0 deaths
Formoterol 12 μg
Serious events: 15 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 participants at risk
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 participants at risk
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 participants at risk
Administered BID by inhalation
|
Formoterol 12 μg
n=332 participants at risk
Administered BID by inhalation
|
Placebo
n=332 participants at risk
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
General disorders
Fatigue
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.60%
2/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.60%
2/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.60%
2/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Pneumonia
|
0.60%
2/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.90%
3/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.90%
3/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
General disorders
Asthenia
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Nervous system disorders
Convulsion
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.60%
2/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.60%
2/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
General disorders
Death
|
0.30%
1/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.30%
1/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
0.00%
0/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
Other adverse events
| Measure |
Aclidinium/Formoterol 400/12 μg
n=335 participants at risk
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium/Formoterol 400/6 μg
n=333 participants at risk
Fixed-dose combination (FDC) administered BID by inhalation
|
Aclidinium 400 μg
n=337 participants at risk
Administered BID by inhalation
|
Formoterol 12 μg
n=332 participants at risk
Administered BID by inhalation
|
Placebo
n=332 participants at risk
Administered BID by inhalation
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.8%
16/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
5.1%
17/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
3.6%
12/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
6.6%
22/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
3.6%
12/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
17/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
3.9%
13/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
2.1%
7/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
3.0%
10/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
3.6%
12/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
15.2%
51/335 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
14.7%
49/333 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
16.9%
57/337 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
16.0%
53/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
17.5%
58/332 • Week 26 ± 5 days
Safety population comprised all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results by the Investigator will be subject to mutual agreement between the investigator and sponsor.
- Publication restrictions are in place
Restriction type: OTHER