Trial Outcomes & Findings for Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients (NCT NCT00144339)
NCT ID: NCT00144339
Last Updated: 2014-05-20
Results Overview
Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5993 participants
Primary outcome timeframe
From day 30 to 4 years
Results posted on
2014-05-20
Participant Flow
09 Jan 2003 - 22 Feb 2008; 490 centers in 37 countries
Participant milestones
| Measure |
Placebo
once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
once daily
|
|---|---|---|
|
Overall Study
STARTED
|
3006
|
2986
|
|
Overall Study
COMPLETED
|
1648
|
1887
|
|
Overall Study
NOT COMPLETED
|
1358
|
1099
|
Reasons for withdrawal
| Measure |
Placebo
once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
746
|
627
|
|
Overall Study
Protocol Violation
|
75
|
48
|
|
Overall Study
Withdrawal by Subject
|
403
|
300
|
|
Overall Study
Lost to Follow-up
|
76
|
64
|
|
Overall Study
Other
|
58
|
60
|
Baseline Characteristics
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
Total
n=5992 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.52 years
STANDARD_DEVIATION 8.48 • n=99 Participants
|
64.50 years
STANDARD_DEVIATION 8.41 • n=107 Participants
|
64.51 years
STANDARD_DEVIATION 8.45 • n=206 Participants
|
|
Sex: Female, Male
Female
|
784 Participants
n=99 Participants
|
735 Participants
n=107 Participants
|
1519.0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2222 Participants
n=99 Participants
|
2251 Participants
n=107 Participants
|
4473.0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From day 30 to 4 yearsRate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Outcome measures
| Measure |
Placebo
n=2413 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2557 Participants
Once daily
|
|---|---|---|
|
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
|
-30 ml/year
Standard Error 1
|
-30 ml/year
Standard Error 1
|
PRIMARY outcome
Timeframe: From day 30 to 4 yearsRate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Outcome measures
| Measure |
Placebo
n=2410 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2554 Participants
Once daily
|
|---|---|---|
|
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
|
-42 ml/year
Standard Error 1
|
-40 ml/year
Standard Error 1
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Outcome measures
| Measure |
Placebo
n=1618 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=1803 Participants
Once daily
|
|---|---|---|
|
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
|
-17 ml/year
Standard Error 2
|
-15 ml/year
Standard Error 2
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 daysRate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Outcome measures
| Measure |
Placebo
n=1613 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=1805 Participants
Once daily
|
|---|---|---|
|
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
|
-32 ml/year
Standard Error 2
|
-27 ml/year
Standard Error 2
|
SECONDARY outcome
Timeframe: From day 30 to 4 yearsRate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Outcome measures
| Measure |
Placebo
n=2413 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2557 Participants
Once daily
|
|---|---|---|
|
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
|
-39 ml/year
Standard Error 3
|
-43 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: From day 30 to 4 yearsRate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Outcome measures
| Measure |
Placebo
n=2410 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2554 Participants
Once daily
|
|---|---|---|
|
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
|
-61 ml/year
Standard Error 3
|
-61 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: From day 30 to 4 yearsRate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2531 Participants
Once daily
|
|---|---|---|
|
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
|
-41 ml/year
Standard Error 3
|
-47 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: From day 30 to 4 yearsRate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Outcome measures
| Measure |
Placebo
n=2383 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2527 Participants
Once daily
|
|---|---|---|
|
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
|
-65 ml/year
Standard Error 3
|
-66 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: From month 6 to 4 yearsSGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).
Outcome measures
| Measure |
Placebo
n=2362 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2505 Participants
Once daily
|
|---|---|---|
|
Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
|
1.21 Score on scale per year
Standard Error 0.09
|
1.25 Score on scale per year
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Outcome measures
| Measure |
Placebo
n=1618 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=1803 Participants
Once daily
|
|---|---|---|
|
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
|
-12 ml/year
Standard Error 4
|
-10 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 daysRate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Outcome measures
| Measure |
Placebo
n=1613 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=1805 Participants
Once daily
|
|---|---|---|
|
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
|
-40 ml/year
Standard Error 4
|
-40 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 daysRate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Outcome measures
| Measure |
Placebo
n=1562 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=1706 Participants
Once daily
|
|---|---|---|
|
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
|
-17 ml/year
Standard Error 4
|
-17 ml/year
Standard Error 4
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 daysRate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Outcome measures
| Measure |
Placebo
n=1540 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=1711 Participants
Once daily
|
|---|---|---|
|
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
|
-46 ml/year
Standard Error 4
|
-42 ml/year
Standard Error 3
|
SECONDARY outcome
Timeframe: From Day 1 to 4 yearsChronic obstructive pulmonary disease (COPD) exacerbation
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Time to First Exacerbation
|
12.51 months
Interval 11.53 to 13.79
|
16.65 months
Interval 14.88 to 17.87
|
SECONDARY outcome
Timeframe: Day 1 to 4 yearsOutcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
|
0.85 number per patient year
Standard Error 0.02
|
0.73 number per patient year
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Day 1 to 4 yearsOutcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Number of patients
|
2049 Participants
|
2001 Participants
|
|
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Percentage of patients
|
68.2 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Day 1 to 4 yearsNumber of exacerbation days normalized by treatment exposure
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number of Exacerbation Days Per Patient Year
|
13.64 days/patient year
Standard Error 0.35
|
12.11 days/patient year
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Day 1 to 4 yearsOutcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
|
28.64 months
Interval 26.08 to 31.82
|
35.89 months
Interval 23.38 to 39.54
|
SECONDARY outcome
Timeframe: From Day 1 to 4 yearsOutcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Number of patients
|
811 Participants
|
759 Participants
|
|
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Percentage of patients
|
27 Participants
|
25.4 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to 4 yearsEstimated number of exacerbations leading to hospitalizations per patient year
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number of Exacerbation Leading to Hospitalization
|
0.16 Number per patient year
|
0.15 Number per patient year
|
SECONDARY outcome
Timeframe: From Day 1 to 4 yearsNumber of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
|
3.13 days/patient year
Standard Error 0.17
|
3.17 days/patient year
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Month 1Estimated FEV1 before bronchodilator at Month 1
Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
|
1.134 L
Standard Error 0.004
|
1.221 L
Standard Error 0.004
|
SECONDARY outcome
Timeframe: Month 1Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
|
1.372 L
Standard Error 0.004
|
1.418 L
Standard Error 0.004
|
SECONDARY outcome
Timeframe: Month 6Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
|
1.126 L
Standard Error 0.004
|
1.225 L
Standard Error 0.004
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
|
1.365 L
Standard Deviation 0.004
|
1.423 L
Standard Deviation 0.004
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
|
1.111 L
Standard Error 0.004
|
1.213 L
Standard Error 0.004
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
|
1.345 L
Standard Error 0.004
|
1.398 L
Standard Error 0.004
|
SECONDARY outcome
Timeframe: Month 18Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
|
1.101 L
Standard Error 0.005
|
1.192 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 18Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
|
1.326 L
Standard Error 0.005
|
1.379 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 24Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
|
1.079 L
Standard Error 0.005
|
1.173 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 24Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
|
1.294 L
Standard Error 0.005
|
1.356 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 30Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
|
1.061 L
Standard Error 0.005
|
1.156 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 30Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
|
1.274 L
Standard Error 0.005
|
1.335 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 36Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
|
1.045 L
Standard Error 0.005
|
1.144 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 36Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
|
1.250 L
Standard Error 0.005
|
1.315 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 42Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
|
1.034 L
Standard Error 0.005
|
1.129 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 42Estimated FEV1 after bronchodilator at Month 42
Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
|
1.236 L
Standard Error 0.006
|
1.297 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 48Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
|
1.024 L
Standard Error 0.006
|
1.112 L
Standard Error 0.005
|
SECONDARY outcome
Timeframe: Month 48Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
|
1.219 L
Standard Error 0.006
|
1.268 L
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Month 1Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
|
2.667 L
Standard Error 0.008
|
2.856 L
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Month 1Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
|
3.149 L
Standard Error 0.007
|
3.204 L
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
|
2.658 L
Standard Error 0.009
|
2.862 L
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
|
3.137 L
Standard Error 0.008
|
3.193 L
Standard Error 0.007
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
|
2.640 L
Standard Error 0.009
|
2.838 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
|
3.110 L
Standard Error 0.008
|
3.158 L
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Month 18Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
|
2.622 L
Standard Error 0.010
|
2.816 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 18Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
|
3.075 L
Standard Error 0.009
|
3.126 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 24Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
|
2.597 L
Standard Error 0.010
|
2.785 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 24Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
|
3.036 L
Standard Error 0.009
|
3.095 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 30Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
|
2.572 L
Standard Error 0.010
|
2.757 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 30Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
|
3.010 L
Standard Error 0.010
|
3.057 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 36Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
|
2.553 L
Standard Error 0.011
|
2.753 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 36Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
|
2.973 L
Standard Error 0.010
|
3.038 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 42Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
|
2.540 L
Standard Error 0.011
|
2.724 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Month 42Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
|
2.959 L
Standard Error 0.011
|
3.005 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 48Outcome measures
| Measure |
Placebo
n=2363 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2494 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
|
2.532 L
Standard Error 0.011
|
2.702 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Month 48Outcome measures
| Measure |
Placebo
n=2374 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2516 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
|
2.929 L
Standard Error 0.011
|
2.961 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 1Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
|
2.847 L
Standard Error 0.008
|
3.017 L
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Month 1Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
|
3.280 L
Standard Error 0.007
|
3.318 L
Standard Error 0.007
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
|
2.841 L
Standard Error 0.009
|
3.027 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
|
3.268 L
Standard Error 0.008
|
3.304 L
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
|
2.820 L
Standard Error 0.009
|
2.996 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
|
3.228 L
Standard Error 0.008
|
3.260 L
Standard Error 0.008
|
SECONDARY outcome
Timeframe: Month 18Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
|
2.811 L
Standard Error 0.010
|
2.965 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 18Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
|
3.195 L
Standard Error 0.009
|
3.234 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 24Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
|
2.775 L
Standard Error 0.010
|
2.942 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 24Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
|
3.157 L
Standard Error 0.009
|
3.189 L
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Month 30Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
|
2.738 L
Standard Error 0.011
|
2.908 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 30Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
|
3.126 L
Standard Error 0.010
|
3.157 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 36Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
|
2.731 L
Standard Error 0.011
|
2.897 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 36Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
|
3.086 L
Standard Error 0.010
|
3.136 L
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Month 42Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
|
2.713 L
Standard Error 0.011
|
2.875 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Month 42Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
|
3.073 L
Standard Error 0.011
|
3.100 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Month 48Outcome measures
| Measure |
Placebo
n=2325 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2447 Participants
Once daily
|
|---|---|---|
|
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
|
2.696 L
Standard Error 0.012
|
2.846 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Month 48Outcome measures
| Measure |
Placebo
n=2340 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2467 Participants
Once daily
|
|---|---|---|
|
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
|
3.041 L
Standard Error 0.011
|
3.067 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Month 6* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6
|
42.289 Units on a scale
Standard Error 0.240
|
39.409 Units on a scale
Standard Error 0.233
|
SECONDARY outcome
Timeframe: Month 12* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12
|
42.501 Units on a scale
Standard Error 0.253
|
39.730 Units on a scale
Standard Error 0.245
|
SECONDARY outcome
Timeframe: Month 18* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18
|
43.067 Units on a scale
Standard Error 0.278
|
40.474 Units on a scale
Standard Error 0.269
|
SECONDARY outcome
Timeframe: Month 24* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24
|
43.562 Units on a scale
Standard Error 0.297
|
41.178 Units on a scale
Standard Error 0.286
|
SECONDARY outcome
Timeframe: Month 30* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30
|
44.342 Units on a scale
Standard Error 0.315
|
41.919 Units on a scale
Standard Error 0.301
|
SECONDARY outcome
Timeframe: Month 36* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36
|
45.280 Units on a scale
Standard Error 0.326
|
41.935 Units on a scale
Standard Error 0.311
|
SECONDARY outcome
Timeframe: Month 42* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42
|
45.722 Units on a scale
Standard Error 0.342
|
42.905 Units on a scale
Standard Error 0.325
|
SECONDARY outcome
Timeframe: Month 48* SGRQ total score summarizes the impact of COPD on overall patient's health status. * Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. * The scale is continuous. * Rate of decline shows the yearly change of SGRQ total score.
Outcome measures
| Measure |
Placebo
n=2337 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2478 Participants
Once daily
|
|---|---|---|
|
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48
|
45.968 Units on a scale
Standard Error 0.357
|
43.665 Units on a scale
Standard Error 0.338
|
SECONDARY outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 daysOn-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Number of patients with on-treatment death
|
402 Participants
|
374 Participants
|
|
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Percentage patients with on-treatment death
|
13.4 Participants
|
12.5 Participants
|
SECONDARY outcome
Timeframe: Day 1 to day 1470All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Number of patients died from day 1 to day 1470
|
495 Participants
|
446 Participants
|
|
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Percentage of patients died from day 1 to day 1470
|
16.5 Participants
|
14.9 Participants
|
SECONDARY outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 daysThe primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Percentage of patients with lower respiratory
|
4.7 Participants
|
4.4 Participants
|
|
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Number of patients with lower respiratory
|
140 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Day 1 to day 1470The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Number of patients with lower respiratory death
|
173 Participants
|
153 Participants
|
|
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Percentage patients with lower respiratory death
|
5.8 Participants
|
5.1 Participants
|
POST_HOC outcome
Timeframe: Day 1 to day 1440Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)
Number of patients died from day 1 to day 1440
|
491 Participants
|
430 Participants
|
|
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)
Percentage of patients died from day 1 to day 1440
|
16.3 Participants
|
14.4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)
Number of patients with event
|
350 Number of patients with event
|
322 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)
Incidence rate (number of events/100 patient year)
|
4.21 Number of patients with event
|
3.56 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Angina)
Number of patients with event
|
31 Number of patients with event
|
48 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Angina)
Incidence rate (number events/100-patient years)
|
0.36 Number of patients with event
|
0.51 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)
Number of patients with event
|
67 Number of patients with event
|
69 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)
Incidence rate (number events/100-patient years)
|
0.77 Number of patients with event
|
0.74 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)
Number of patients with event
|
42 Number of patients with event
|
57 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)
Incidence rate (number events/100-patient years)
|
0.48 Number of patients with event
|
0.61 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)
Number of patients with event
|
42 Number of patients with event
|
27 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)
Incidence rate (number events/100-patient years)
|
0.48 Number of patients with event
|
0.29 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)
Number of patients with event
|
32 Number of patients with event
|
20 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)
Incidence rate (number events/100-patient years)
|
0.37 Number of patients with event
|
0.21 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)
Incidence rate (number events/100-patient years)
|
0.97 Number of patients with event
|
0.69 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)
Number of patients with event
|
84 Number of patients with event
|
65 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)
Number of patients with event
|
985 Number of patients with event
|
911 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)
Incidence rate (number events/100-patient years)
|
13.47 Number of patients with event
|
11.32 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)
Number of patients with event
|
27 Number of patients with event
|
35 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)
Incidence rate (number events/100-patient years)
|
0.31 Number of patients with event
|
0.37 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)
Number of patients with event
|
742 Number of patients with event
|
688 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)
Incidence rate (number events/100-patient years)
|
9.70 Number of patients with event
|
8.19 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)
Number of patients with event
|
54 Number of patients with event
|
36 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)
Incidence rate (number events/100-patient years)
|
0.62 Number of patients with event
|
0.38 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)
Number of patients with event
|
290 Number of patients with event
|
296 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)
Incidence rate (number events/100-patient years)
|
3.46 Number of patients with event
|
3.28 Number of patients with event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to completion of double blinded treatment plus 30 daysDescriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years \* 100.
Outcome measures
| Measure |
Placebo
n=3006 Participants
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
n=2986 Participants
Once daily
|
|---|---|---|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)
Number of patients with event
|
113 Number of patients with event
|
85 Number of patients with event
|
|
Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)
Incidence rate (number events/100-patient years)
|
1.31 Number of patients with event
|
0.90 Number of patients with event
|
Adverse Events
Placebo
Serious events: 1509 serious events
Other events: 2622 other events
Deaths: 0 deaths
Tiotropium Bromide Inhalation Capsules 18 mcg
Serious events: 1540 serious events
Other events: 2643 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
Once daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.73%
22/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.77%
23/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma of skin
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.37%
11/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage II
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage IV
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of bladder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.37%
11/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage II
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
11/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.64%
19/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Acute right ventricular failure
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Angina
|
1.0%
31/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.6%
48/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Aortic valve disease
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Aortic valve incompetence
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Arrhythmia
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrial Fibrillation
|
2.2%
67/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
2.3%
69/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrial thrombosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Bradycardia
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Bundle branch block right
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac aneurysm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac arrest
|
0.37%
11/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac disorder
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac failure
|
1.4%
42/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.9%
57/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac failure acute
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac failure chronic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
42/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.90%
27/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac valve disease
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiac ventricular disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiogenic shock
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiomegaly
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiomyopathy
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.33%
10/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cor pulmonale
|
0.50%
15/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.40%
12/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cor pulmonale acute
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
32/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.67%
20/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery embolism
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery restenosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Hypertensive heart disease
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Intracardiac thrombus
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Left ventricular failure
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Mitral valve incompetence
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
84/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
2.2%
65/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Myocardial ischaemia
|
0.43%
13/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.33%
10/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Myocarditis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Palpitations
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Right ventricular failure
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Sick sinus syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Tachyarrhythmia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Tachycardia
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Torsade de pointes
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Ventricular fibrillation
|
0.30%
9/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Cardiac disorders
Ventricular tachycardia
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Congenital myopathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Dolichocolon
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Neurofibromatosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Deafness
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Vertigo
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Endocrine disorders
Diabetes insipidus
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Endocrine disorders
Hyperparathyroidism
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Endocrine disorders
Hyperthyroidism
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Amaurosis fugax
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Cataract
|
0.70%
21/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.77%
23/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Conjunctivitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Eye pain
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Glaucoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Iridocele
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Retinal detachment
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Retinal tear
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Retinal vein occlusion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Vision blurred
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Visual disturbance
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Abdominal distension
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
18/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.60%
18/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Ascites
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Coeliac disease
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Colitis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Colonic polyp
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Constipation
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Diverticulum
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Duodenitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Dysphagia
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Faecaloma
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Femoral hernia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Flatulence
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastric polyps
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastritis
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.53%
16/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.37%
11/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Haematemesis
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Haematochezia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Ileitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Ileus
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.70%
21/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.67%
20/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Internal hernia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal angina
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal mucosal hypertrophy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Loose tooth
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Melaena
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Oesophagitis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Parotid lipomatosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Peritonitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Rectal polyp
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Subileus
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Accidental death
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Adverse drug reaction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Asthenia
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Cardiac death
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Chest discomfort
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Chest pain
|
0.63%
19/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.77%
23/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Cyst rupture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Death
|
0.80%
24/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.0%
31/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Fatigue
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
General physical health deterioration
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Impaired healing
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Influenza like illness
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Multi-organ disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Multi-organ failure
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Multimorbidity
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Non-cardiac chest pain
|
0.67%
20/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.60%
18/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Oedema
|
0.47%
14/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Pain
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Perforated ulcer
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Polyp
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Pyrexia
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Sudden cardiac death
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Sudden death
|
0.37%
11/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.33%
10/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
General disorders
Ulcer
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Bile duct stone
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholangitis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
18/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.37%
11/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Cholestasis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Immune system disorders
Anaphylactic shock
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Immune system disorders
Food allergy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Abdominal infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Abdominal wall abscess
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Abscess
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Abscess intestinal
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Abscess limb
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Appendicitis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Arthritis infective
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Bacteraemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Biliary tract infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Cellulitis
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Clostridium difficile colitis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Corynebacterium infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Dengue fever
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Dermo-hypodermitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Device related infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Diverticulitis
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Empyema
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Endocarditis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Enterococcal sepsis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Fungaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Gangrene
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Gastritis viral
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Gastroenteritis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Gastroenteritis viral
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Groin abscess
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Haemorrhoid infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Hydrocele male infected
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Incision site infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Intertrigo candida
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Intervertebral discitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Joint abscess
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Localised infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Meningitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Meningitis listeria
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Meningococcal bacteraemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Necrotising fasciitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Nosocomial infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Orchitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Osteomyelitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Otitis media
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Parotitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Periodontal infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Periorbital cellulitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Perirectal abscess
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Peritoneal infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Pneumococcal sepsis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Post procedural pneumonia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Postoperative wound infection
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Pseudomonas infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Sepsis
|
0.86%
26/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.54%
16/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Sepsis syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Septic shock
|
0.37%
11/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Skin infection
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Staphylococcal sepsis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Tuberculosis
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Urinary tract infection
|
0.57%
17/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.80%
24/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Urosepsis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Wound infection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Wound sepsis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Back injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Burn of internal organs
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Bursa injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Concussion
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Decerebration
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Face injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.64%
19/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Head injury
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Internal injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Overdose
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Pancreatic injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Post gastric surgery syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Stent-graft endoleak
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Urinary tract injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Blood calcium decreased
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Blood glucose increased
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Blood pressure increased
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Body temperature increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Cardiac murmur
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Heart rate irregular
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Investigation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Oxygen saturation decreased
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Physical examination
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Platelet count decreased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Urine calcium increased
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Urine output decreased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
Weight decreased
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Investigations
White blood cell count increased
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Acidosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Cachexia
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.47%
14/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Myopathy steroid
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.67%
20/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.94%
28/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage 0
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage I
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage III
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna stage unspecified
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymph node cancer metastatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage II
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pericardial neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant urinary tract neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to breast
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.30%
9/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.33%
10/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm recurrence
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma metastatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.73%
22/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.0%
31/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Altered state of consciousness
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Amnesia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Aphasia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Brain injury
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Brain oedema
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Carotid artery disease
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Carotid artery occlusion
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Carotid artery stenosis
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebral haematoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebral ischaemia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebrovascular accident
|
0.93%
28/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.94%
28/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Coma
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Coma hepatic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Convulsion
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Dementia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Depressed level of consciousness
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Diabetic coma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Dizziness
|
0.30%
9/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Dysarthria
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Encephalitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Encephalopathy
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Epilepsy
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Global amnesia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Grand mal convulsion
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Headache
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Hemiparesis
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Hemiplegia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Hyperaesthesia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Hypercapnic encephalopathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Intracranial haematoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Intracranial hypotension
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Lethargy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Locked-in syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Migraine
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Neuralgia
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Neuropathy peripheral
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Paralysis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Paraparesis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Paresis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Presyncope
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Radiculitis cervical
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Radiculopathy
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Somnolence
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Spinal cord compression
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Spinal cord infarction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Status epilepticus
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Syncope
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.44%
13/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Transient ischaemic attack
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.47%
14/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Tremor
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Agitation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Alcoholism
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Anxiety
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Completed suicide
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Confusional state
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Delirium
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Depressed mood
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Depression
|
0.30%
9/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Disorientation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Drug dependence
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Dysthymic disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Hallucination, auditory
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Insomnia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Major depression
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Nicotine dependence
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Panic attack
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Suicidal ideation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Psychiatric disorders
Tobacco withdrawal symptoms
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Calculus urinary
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Haematuria
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal aneurysm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal failure
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.44%
13/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal failure acute
|
0.53%
16/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.54%
16/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal pain
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urinary incontinence
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urinary retention
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.50%
15/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.47%
14/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.67%
20/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Organic erectile dysfunction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Prostatism
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Prostatitis
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Actinomycotic pulmonary infection
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
31/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.97%
29/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Aspergilloma
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.90%
27/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.2%
35/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary aspergillosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
24.7%
742/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
23.0%
688/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Cryptogenic organising pneumonia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
54/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.2%
36/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.30%
9/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.33%
10/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.47%
14/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.40%
12/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung abscess
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection pseudomonal
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung injury
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Middle lobe syndrome
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumocystis jiroveci pneumonia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia klebsiella
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia necrotising
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia staphylococcal
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
9.6%
290/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
9.9%
296/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.80%
24/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.87%
26/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax traumatic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pseudomonas bronchitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary bulla
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary tuberculoma
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary tuberculosis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pyothorax
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Radiation pneumonitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.8%
113/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
2.8%
85/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory fume inhalation disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Benign lung neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial carcinoma
|
0.30%
9/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.50%
15/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial neoplasm
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchogenic cyst
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Cyanosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypopharyngeal cancer
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.40%
12/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Large cell carcinoma of the respir. tract stage unspecified
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal cancer
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung adenocarcinoma
|
0.37%
11/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung adenocarcinoma metastatic
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung adenocarcinoma recurrent
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer metastatic
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung carcinoma cell type unspecified stage 0
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung carcinoma cell type unspecified stage III
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm
|
0.23%
7/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.40%
12/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
|
1.1%
34/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
1.3%
40/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung squamous cell carcinoma stage III
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung squamous cell carcinoma stage IV
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung squamous cell carcinoma stage unspecified
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Lymphadenopathy mediastinal
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Malignant mediastinal neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinum neoplasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Metastases to lung
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Metastatic bronchial carcinoma
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer
|
0.40%
12/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.33%
10/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer metastatic
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cancer stage unspecified
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.96%
29/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.84%
25/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Scoliosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Small cell lung cancer extensive stage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Small cell lung cancer limited stage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Small cell lung cancer metastatic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Small cell lung cancer stage unspecified
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.27%
8/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Throat cancer
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal neoplasm
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Chronic tonsillitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal abscess
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngoesophageal diverticulum
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal abscess
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Tracheostomy malfunction
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.43%
13/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.64%
19/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord paralysis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Social circumstances
Alcohol use
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Social circumstances
Social problem
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Social circumstances
Social stay hospitalisation
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Social circumstances
Victim of homicide
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Adhesiolysis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Bladder operation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Catheter placement
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Finger amputation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Gastrointestinal tube insertion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Nasal polypectomy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Oxygen supplementation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Respiratory therapy
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Surgery
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic aneurysm
|
0.37%
11/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.50%
15/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic disorder
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic rupture
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic stenosis
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arterial disorder
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arterial occlusive disease
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arterial thrombosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arterial thrombosis limb
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arteriosclerosis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Arteritis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Bleeding varicose vein
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Circulatory collapse
|
0.20%
6/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
8/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.47%
14/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Embolism
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Haematoma
|
0.17%
5/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Hypertension
|
0.43%
13/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.37%
11/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Hypertensive crisis
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Hypotension
|
0.30%
9/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.37%
11/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Iliac artery stenosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Ischaemia
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Jugular vein thrombosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.17%
5/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.23%
7/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Peripheral vascular disorder
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.10%
3/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Shock
|
0.13%
4/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.13%
4/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Shock haemorrhagic
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Superior vena caval occlusion
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.20%
6/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Varicose ulceration
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Varicose vein
|
0.07%
2/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Vascular shunt
|
0.00%
0/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Venous stasis
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Venous thrombosis
|
0.10%
3/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.03%
1/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Venous thrombosis limb
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.07%
2/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Wound haemorrhage
|
0.03%
1/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
0.00%
0/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
Other adverse events
| Measure |
Placebo
Once daily
|
Tiotropium Bromide Inhalation Capsules 18 mcg
Once daily
|
|---|---|---|
|
Gastrointestinal disorders
Mouth dry
|
2.7%
80/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
5.1%
152/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Infections and infestations
Urinary tract infection
|
5.2%
157/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
5.8%
173/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
179/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
6.4%
190/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Nervous system disorders
Headache
|
4.5%
135/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
5.7%
169/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
7.1%
214/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
6.9%
207/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
58.0%
1743/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
57.1%
1706/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
212/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
7.9%
236/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.4%
404/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
11.3%
338/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.2%
156/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
5.3%
157/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
5.2%
155/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
5.1%
153/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
10.7%
323/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
12.5%
373/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.2%
157/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
6.4%
190/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
9.4%
282/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
9.5%
285/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
|
Vascular disorders
Hypertension
|
9.1%
273/3006 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
8.9%
265/2986 • From first drug administration until 30 days after last drug administration
The Dictionary used to report the adverse events is Sponsor-defined based on the MedDRA version 11.0
|
Additional Information
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER