Trial Outcomes & Findings for A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation (NCT NCT01682863)
NCT ID: NCT01682863
Last Updated: 2016-03-30
Results Overview
The overall rate of adverse events reported from initiation through 30 days post last dose.
COMPLETED
PHASE3
614 participants
56 weeks
2016-03-30
Participant Flow
Patients were randomized to each treatment arm in 1:1:1 ratio.
Six hundred fifteen patients were randomized. One patient was randomized but did not receive treatment due to an adverse event. In the safety set, patients were analyzed according to the treatment received. Therefore, protocol enrollment and analysis set was 614 but the participant flow was 615
Participant milestones
| Measure |
QVA149 27.5/12.5 ug Bid
|
QVA149 27.5/25 ug Bid
|
QAB149 75 ug od
|
|---|---|---|---|
|
Overall Study
STARTED
|
204
|
204
|
207
|
|
Overall Study
Safety Set
|
204
|
204
|
206
|
|
Overall Study
Full Analysis Set (FAS)
|
204
|
204
|
206
|
|
Overall Study
Randomized Set
|
204
|
204
|
207
|
|
Overall Study
COMPLETED
|
177
|
187
|
183
|
|
Overall Study
NOT COMPLETED
|
27
|
17
|
24
|
Reasons for withdrawal
| Measure |
QVA149 27.5/12.5 ug Bid
|
QVA149 27.5/25 ug Bid
|
QAB149 75 ug od
|
|---|---|---|---|
|
Overall Study
Subject/guardian decision
|
19
|
12
|
10
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
6
|
|
Overall Study
Death
|
1
|
3
|
4
|
|
Overall Study
Protocol deviation
|
1
|
0
|
1
|
|
Overall Study
Technical problems
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Baseline characteristics by cohort
| Measure |
QVA149 27.5/12.5 ug Bid
n=204 Participants
|
QVA149 27.5/25 ug Bid
n=204 Participants
|
QAB149 75 ug od
n=207 Participants
|
Total
n=615 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 7.90 • n=5 Participants
|
63.9 Years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
62.8 Years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 8.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
403 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 56 weeksPopulation: The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.
The overall rate of adverse events reported from initiation through 30 days post last dose.
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=204 Participants
|
QVA149 27.5/25 ug Bid
n=204 Participants
|
QAB149 75 ug od
n=206 Participants
|
|---|---|---|---|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Patients with at least one SAEs
|
26 Number of Patients
|
25 Number of Patients
|
24 Number of Patients
|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Patients with at least one AE
|
139 Number of Patients
|
142 Number of Patients
|
139 Number of Patients
|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Death
|
1 Number of Patients
|
3 Number of Patients
|
5 Number of Patients
|
SECONDARY outcome
Timeframe: 56 weeksPopulation: The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.
methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=204 Participants
|
QVA149 27.5/25 ug Bid
n=204 Participants
|
QAB149 75 ug od
n=206 Participants
|
|---|---|---|---|
|
Time to Premature Discontinuation of Treatment
|
384.0 Days
95% Confidence Interval 0.164 • Interval 384.0 to
NA- Not estimable
|
NA Days
95% Confidence Interval 0.164
NA- Not estimable
|
NA Days
95% Confidence Interval 0.166
NA- Not estimable
|
SECONDARY outcome
Timeframe: Day 29, 57,, 85, 141, 197, 253, 309 and 365Population: The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 \* visit interaction, and visit, treatment \* visit interaction.
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=192 Participants
|
QVA149 27.5/25 ug Bid
n=196 Participants
|
QAB149 75 ug od
n=199 Participants
|
|---|---|---|---|
|
Change From Baseline in Pre-dose Trough FEV1
Day 197
|
0.138 Liters
Standard Error 0.0167
|
0.181 Liters
Standard Error 0.0165
|
0.079 Liters
Standard Error 0.0166
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 253
|
0.142 Liters
Standard Error 0.0168
|
0.153 Liters
Standard Error 0.0165
|
0.074 Liters
Standard Error 0.0167
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 309
|
0.096 Liters
Standard Error 0.0162
|
0.123 Liters
Standard Error 0.0161
|
0.050 Liters
Standard Error 0.0162
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 29
|
0.164 Liters
Standard Error 0.0144
|
0.194 Liters
Standard Error 0.0143
|
0.109 Liters
Standard Error 0.0143
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 57
|
0.178 Liters
Standard Error 0.0151
|
0.199 Liters
Standard Error 0.0149
|
0.107 Liters
Standard Error 0.0149
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 85
|
0.166 Liters
Standard Error 0.0158
|
0.201 Liters
Standard Error 0.0157
|
0.095 Liters
Standard Error 0.0157
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 141
|
0.174 Liters
Standard Error 0.0173
|
0.198 Liters
Standard Error 0.0170
|
0.087 Liters
Standard Error 0.0171
|
|
Change From Baseline in Pre-dose Trough FEV1
Day 365
|
0.116 Liters
Standard Error 0.0169
|
0.116 Liters
Standard Error 0.0167
|
0.037 Liters
Standard Error 0.0169
|
SECONDARY outcome
Timeframe: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365Population: The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 \* visit interaction, and visit, treatment \* visit interaction.
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=200 Participants
|
QVA149 27.5/25 ug Bid
n=202 Participants
|
QAB149 75 ug od
n=202 Participants
|
|---|---|---|---|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 1
|
0.166 Liters
Standard Error 0.0088
|
0.178 Liters
Standard Error 0.0088
|
0.122 Liters
Standard Error 0.0089
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 29
|
0.257 Liters
Standard Error 0.0152
|
0.287 Liters
Standard Error 0.0151
|
0.173 Liters
Standard Error 0.0151
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 57
|
0.267 Liters
Standard Error 0.0157
|
0.302 Liters
Standard Error 0.0155
|
0.173 Liters
Standard Error 0.0154
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 85
|
0.269 Liters
Standard Error 0.0164
|
0.301 Liters
Standard Error 0.0162
|
0.170 Liters
Standard Error 0.0162
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 141
|
0.268 Liters
Standard Error 0.0182
|
0.288 Liters
Standard Error 0.0179
|
0.170 Liters
Standard Error 0.0181
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 197
|
0.229 Liters
Standard Error 0.0178
|
0.278 Liters
Standard Error 0.0175
|
0.157 Liters
Standard Error 0.0177
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 253
|
0.231 Liters
Standard Error 0.0178
|
0.240 Liters
Standard Error 0.0175
|
0.140 Liters
Standard Error 0.0176
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 309
|
0.199 Liters
Standard Error 0.0170
|
0.222 Liters
Standard Error 0.0169
|
0.125 Liters
Standard Error 0.0170
|
|
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Day 365
|
0.212 Liters
Standard Error 0.0175
|
0.221 Liters
Standard Error 0.0173
|
0.104 Liters
Standard Error 0.0174
|
SECONDARY outcome
Timeframe: Day1, 29, 57, 85, 141, 197, 253, 309, and 365Population: The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Pulmonary function assessments were performed using centralized spirometry according to international standards.
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=200 Participants
|
QVA149 27.5/25 ug Bid
n=202 Participants
|
QAB149 75 ug od
n=202 Participants
|
|---|---|---|---|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 1
|
0.316 Liters
Standard Error 0.0201
|
0.349 Liters
Standard Error 0.0200
|
0.248 Liters
Standard Error 0.0203
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 29
|
0.375 Liters
Standard Error 0.0274
|
0.440 Liters
Standard Error 0.0271
|
0.280 Liters
Standard Error 0.0272
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 57
|
0.390 Liters
Standard Error 0.0274
|
0.439 Liters
Standard Error 0.0271
|
0.279 Liters
Standard Error 0.0271
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 85
|
0.388 Liters
Standard Error 0.0287
|
0.432 Liters
Standard Error 0.0283
|
0.268 Liters
Standard Error 0.0284
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 141
|
0.382 Liters
Standard Error 0.0297
|
0.403 Liters
Standard Error 0.0292
|
0.235 Liters
Standard Error 0.0295
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 197
|
0.313 Liters
Standard Error 0.0288
|
0.400 Liters
Standard Error 0.0284
|
0.220 Liters
Standard Error 0.0288
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 253
|
0.310 Liters
Standard Error 0.0303
|
0.365 Liters
Standard Error 0.0298
|
0.205 Liters
Standard Error 0.0301
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 309
|
0.272 Liters
Standard Error 0.0284
|
0.334 Liters
Standard Error 0.0281
|
0.185 Liters
Standard Error 0.0285
|
|
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Day 365
|
0.312 Liters
Standard Error 0.0286
|
0.323 Liters
Standard Error 0.0282
|
0.139 Liters
Standard Error 0.0286
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis.
Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=204 Participants
|
QVA149 27.5/25 ug Bid
n=204 Participants
|
QAB149 75 ug od
n=206 Participants
|
|---|---|---|---|
|
Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
|
23.5 Percentage of participants
|
24.9 Percentage of participants
|
27.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=198 Participants
|
QVA149 27.5/25 ug Bid
n=199 Participants
|
QAB149 75 ug od
n=198 Participants
|
|---|---|---|---|
|
Change From Baseline in Mean Total Daily Symptom Scores
|
-1.57 Score on a scale
Standard Error 0.133
|
-1.56 Score on a scale
Standard Error 0.133
|
-1.31 Score on a scale
Standard Error 0.135
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
Outcome measures
| Measure |
QVA149 27.5/12.5 ug Bid
n=198 Participants
|
QVA149 27.5/25 ug Bid
n=199 Participants
|
QAB149 75 ug od
n=198 Participants
|
|---|---|---|---|
|
Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
|
-1.89 Number of puffs
Standard Error 0.164
|
-1.62 Number of puffs
Standard Error 0.164
|
-1.73 Number of puffs
Standard Error 0.166
|
Adverse Events
QVA149 27.5/12.5 ug Bid
QVA149 27.5/25 ug Bid
QAB75
Serious adverse events
| Measure |
QVA149 27.5/12.5 ug Bid
n=204 participants at risk
|
QVA149 27.5/25 ug Bid
n=204 participants at risk
|
QAB75
n=206 participants at risk
QVA149 27.5/25 μg capsules
|
|---|---|---|---|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/204
|
0.49%
1/204
|
0.49%
1/206
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.98%
2/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.49%
1/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/204
|
0.49%
1/204
|
0.49%
1/206
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Cardiac disorders
SILENT MYOCARDIAL INFARCTION
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Congenital, familial and genetic disorders
ASPLENIA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Gastrointestinal disorders
INGUINAL HERNIA STRANGULATED
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
General disorders
FACIAL PAIN
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Infections and infestations
BRONCHITIS
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Infections and infestations
H1N1 INFLUENZA
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.49%
1/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Infections and infestations
PNEUMONIA
|
2.0%
4/204
|
0.49%
1/204
|
0.97%
2/206
|
|
Infections and infestations
PYELONEPHRITIS
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Infections and infestations
SEPSIS
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION BACTERIAL
|
0.98%
2/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Injury, poisoning and procedural complications
BRAIN HERNIATION
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BONE CANCER
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.49%
1/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
KAPOSI'S SARCOMA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SPINE
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER STAGE IV
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.49%
1/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.49%
1/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF LUNG
|
0.49%
1/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.00%
0/204
|
0.98%
2/204
|
0.00%
0/206
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.49%
1/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
3.9%
8/204
|
2.5%
5/204
|
4.9%
10/206
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Vascular disorders
AORTIC DISSECTION
|
0.49%
1/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/204
|
0.49%
1/204
|
0.00%
0/206
|
|
Vascular disorders
HYPOTENSION
|
0.49%
1/204
|
0.00%
0/204
|
0.00%
0/206
|
Other adverse events
| Measure |
QVA149 27.5/12.5 ug Bid
n=204 participants at risk
|
QVA149 27.5/25 ug Bid
n=204 participants at risk
|
QAB75
n=206 participants at risk
QVA149 27.5/25 μg capsules
|
|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
0.49%
1/204
|
1.5%
3/204
|
0.49%
1/206
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.5%
5/204
|
0.98%
2/204
|
1.5%
3/206
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.0%
4/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Gastrointestinal disorders
NAUSEA
|
0.98%
2/204
|
2.0%
4/204
|
0.49%
1/206
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/204
|
2.5%
5/204
|
1.9%
4/206
|
|
Gastrointestinal disorders
VOMITING
|
1.5%
3/204
|
0.98%
2/204
|
0.00%
0/206
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/204
|
2.0%
4/204
|
1.9%
4/206
|
|
General disorders
OEDEMA PERIPHERAL
|
0.49%
1/204
|
2.9%
6/204
|
2.4%
5/206
|
|
General disorders
PYREXIA
|
1.5%
3/204
|
2.0%
4/204
|
0.00%
0/206
|
|
Infections and infestations
BRONCHITIS
|
0.98%
2/204
|
3.4%
7/204
|
3.9%
8/206
|
|
Infections and infestations
INFLUENZA
|
0.49%
1/204
|
0.98%
2/204
|
1.9%
4/206
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
3.9%
8/204
|
2.0%
4/204
|
2.9%
6/206
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.3%
19/204
|
8.8%
18/204
|
10.7%
22/206
|
|
Infections and infestations
PHARYNGITIS
|
1.5%
3/204
|
0.00%
0/204
|
1.5%
3/206
|
|
Infections and infestations
PNEUMONIA
|
2.5%
5/204
|
1.5%
3/204
|
0.49%
1/206
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
1.5%
3/204
|
0.98%
2/204
|
2.9%
6/206
|
|
Infections and infestations
RHINITIS
|
2.0%
4/204
|
1.5%
3/204
|
0.97%
2/206
|
|
Infections and infestations
SINUSITIS
|
2.5%
5/204
|
3.4%
7/204
|
2.9%
6/206
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.9%
10/204
|
4.9%
10/204
|
4.4%
9/206
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION BACTERIAL
|
4.9%
10/204
|
6.9%
14/204
|
6.3%
13/206
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/204
|
2.0%
4/204
|
1.5%
3/206
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
3.4%
7/204
|
2.9%
6/204
|
3.4%
7/206
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.5%
3/204
|
0.98%
2/204
|
0.49%
1/206
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.5%
3/204
|
0.00%
0/204
|
0.49%
1/206
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.98%
2/204
|
2.5%
5/204
|
1.5%
3/206
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.9%
10/204
|
3.4%
7/204
|
2.4%
5/206
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.49%
1/204
|
2.0%
4/204
|
0.49%
1/206
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/204
|
1.5%
3/204
|
0.49%
1/206
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.5%
3/204
|
0.49%
1/204
|
0.97%
2/206
|
|
Nervous system disorders
HEADACHE
|
2.5%
5/204
|
3.4%
7/204
|
1.9%
4/206
|
|
Psychiatric disorders
INSOMNIA
|
1.5%
3/204
|
0.98%
2/204
|
0.49%
1/206
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
34.3%
70/204
|
31.4%
64/204
|
34.5%
71/206
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.5%
3/204
|
6.4%
13/204
|
3.4%
7/206
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.49%
1/204
|
1.5%
3/204
|
2.9%
6/206
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/204
|
0.49%
1/204
|
1.9%
4/206
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.0%
4/204
|
2.5%
5/204
|
1.5%
3/206
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.49%
1/204
|
1.5%
3/204
|
0.97%
2/206
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.5%
3/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
1.5%
3/204
|
0.00%
0/204
|
0.00%
0/206
|
|
Vascular disorders
HYPERTENSION
|
2.5%
5/204
|
4.9%
10/204
|
1.9%
4/206
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/204
|
1.5%
3/204
|
0.00%
0/206
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER