Trial Outcomes & Findings for Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1) (NCT NCT01854645)
NCT ID: NCT01854645
Last Updated: 2017-03-28
Results Overview
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2103 participants
Primary outcome timeframe
Baseline and at Week 24
Results posted on
2017-03-28
Participant Flow
Conducted at 160 sites throughout the US, Australia, and New Zealand from June 2013 - February 2015. Study participation was a maximum of 32 weeks.
Study was a multicenter, randomized, double-blind, parallel group, chronic dosing, active- and placebo-controlled study; each patient was randomized to receive 1 of 5 possible treatments over the course of a 24-week treatment period
Participant milestones
| Measure |
GFF MDI (PT003)
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
Placebo MDI
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
527
|
451
|
452
|
453
|
220
|
|
Overall Study
COMPLETED
|
429
|
345
|
370
|
391
|
160
|
|
Overall Study
NOT COMPLETED
|
98
|
106
|
82
|
62
|
60
|
Reasons for withdrawal
| Measure |
GFF MDI (PT003)
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
Placebo MDI
|
|---|---|---|---|---|---|
|
Overall Study
Protocol-Specified Criteria
|
13
|
10
|
8
|
5
|
7
|
|
Overall Study
Administrative Reasons / Missing
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
0
|
5
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
8
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
5
|
3
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
31
|
41
|
30
|
21
|
24
|
|
Overall Study
Lack of Efficacy
|
7
|
12
|
9
|
3
|
9
|
|
Overall Study
Adverse Event
|
33
|
31
|
19
|
20
|
11
|
Baseline Characteristics
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
Baseline characteristics by cohort
| Measure |
GFF MDI (PT003)
n=526 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=451 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=449 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=451 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=219 Participants
Placebo MDI
|
Total
n=2096 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
62.9 Years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
63.0 Years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
63.0 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
62.5 Years
STANDARD_DEVIATION 8.3 • n=31 Participants
|
62.8 Years
STANDARD_DEVIATION 8.4 • n=30 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
182 Participants
n=7 Participants
|
97 Participants
n=31 Participants
|
914 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
290 Participants
n=99 Participants
|
255 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
269 Participants
n=7 Participants
|
122 Participants
n=31 Participants
|
1182 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and at Week 24Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Outcome measures
| Measure |
GFF MDI (PT003)
n=429 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=344 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=367 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=390 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=161 Participants
Placebo MDI
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
|
0.126 Liters
Interval 0.107 to 0.145
|
0.066 Liters
Interval 0.045 to 0.087
|
0.062 Liters
Interval 0.041 to 0.082
|
0.105 Liters
Interval 0.084 to 0.125
|
-0.024 Liters
Interval -0.055 to 0.007
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2 to 24Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Outcome measures
| Measure |
GFF MDI (PT003)
n=519 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=440 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=439 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=446 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=208 Participants
Placebo MDI
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
|
0.150 Liters
Interval 0.136 to 0.164
|
0.091 Liters
Interval 0.076 to 0.106
|
0.086 Liters
Interval 0.071 to 0.101
|
0.122 Liters
Interval 0.107 to 0.137
|
-0.007 Liters
Interval -0.029 to 0.015
|
SECONDARY outcome
Timeframe: Baseline and at Week 24Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Outcome measures
| Measure |
GFF MDI (PT003)
n=503 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=425 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=434 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=435 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=213 Participants
Placebo MDI
|
|---|---|---|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ) Score
|
-3.1 Scores on a scale
Interval -4.0 to -2.2
|
-1.2 Scores on a scale
Interval -2.2 to -0.2
|
-2.4 Scores on a scale
Interval -3.4 to -1.4
|
-2.7 Scores on a scale
Interval -3.6 to -1.7
|
-0.8 Scores on a scale
Interval -2.2 to 0.7
|
SECONDARY outcome
Timeframe: Baseline and at Week 24Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure
Change from baseline in average daily rescue Ventolin HFA use
Outcome measures
| Measure |
GFF MDI (PT003)
n=525 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=449 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=446 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=449 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=218 Participants
Placebo MDI
|
|---|---|---|---|---|---|
|
Rescue Ventolin Hydrofluoroalkane (HFA) Use
|
-0.8 Puffs / Day
Interval -1.0 to -0.6
|
-0.5 Puffs / Day
Interval -0.7 to -0.3
|
-0.8 Puffs / Day
Interval -1.0 to -0.6
|
-0.4 Puffs / Day
Interval -0.6 to -0.2
|
0.3 Puffs / Day
Interval 0.0 to 0.6
|
SECONDARY outcome
Timeframe: Assessed for 5- and 15-minute post dose on Day 1Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Outcome measures
| Measure |
GFF MDI (PT003)
n=418 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=363 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=366 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=364 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=172 Participants
Placebo MDI
|
|---|---|---|---|---|---|
|
Onset of Action as Assessed by FEV1
5 min post dose
|
0.185 Liters
Interval 0.175 to 0.195
|
0.042 Liters
Interval 0.031 to 0.053
|
0.182 Liters
Interval 0.171 to 0.193
|
0.048 Liters
Interval 0.037 to 0.059
|
-0.002 Liters
Interval -0.017 to 0.014
|
|
Onset of Action as Assessed by FEV1
15 min post dose
|
0.226 Liters
Interval 0.216 to 0.237
|
0.101 Liters
Interval 0.09 to 0.113
|
0.212 Liters
Interval 0.201 to 0.224
|
0.117 Liters
Interval 0.105 to 0.129
|
0.022 Liters
Interval 0.005 to 0.038
|
SECONDARY outcome
Timeframe: Baseline and at Week 24Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Outcome measures
| Measure |
GFF MDI (PT003)
n=428 Participants
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=343 Participants
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=367 Participants
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=388 Participants
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=160 Participants
Placebo MDI
|
|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
|
0.356 Liters
Interval 0.335 to 0.377
|
0.223 Liters
Interval 0.2 to 0.246
|
0.263 Liters
Interval 0.24 to 0.285
|
0.259 Liters
Interval 0.237 to 0.281
|
0.065 Liters
Interval 0.031 to 0.098
|
Adverse Events
GFF MDI (PT003)
Serious events: 44 serious events
Other events: 73 other events
Deaths: 0 deaths
GP MDI (PT001)
Serious events: 36 serious events
Other events: 59 other events
Deaths: 0 deaths
FF MDI (PT005)
Serious events: 29 serious events
Other events: 57 other events
Deaths: 0 deaths
Spiriva® Handihaler® (Open-label)
Serious events: 36 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GFF MDI (PT003)
n=526 participants at risk
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=451 participants at risk
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=452 participants at risk
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=451 participants at risk
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=220 participants at risk
Placebo MDI
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.9%
15/526 • Number of events 15 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.8%
17/451 • Number of events 20 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
1.8%
8/452 • Number of events 8 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
1.8%
8/451 • Number of events 8 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.2%
7/220 • Number of events 7 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.44%
2/452 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Epistatxis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Pneumonia
|
1.5%
8/526 • Number of events 8 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
1.6%
7/451 • Number of events 7 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Cellulitis
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.44%
2/451 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Lobar pneumonia
|
0.38%
2/526 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Sepsis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Bronchitis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Influenza
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Opthalmic herpes zoster
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 3 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrial tachycardia
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Cardiac arrest
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.67%
3/451 • Number of events 3 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage 0
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Translational cell carcinoma
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.44%
2/451 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Afferent loop syndrome
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.44%
2/452 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Peripheral vascular disorder
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Hypotension
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Peripheral artery stenosis
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Constipation
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
General disorders
Chest pain
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.44%
2/451 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.91%
2/220 • Number of events 2 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
General disorders
Inflamation
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
General disorders
Pyrexia
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
General disorders
Sudden cardiac death
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Syncope
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Depression
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/451 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Renal and urinary disorders
Bladder cyst
|
0.19%
1/526 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.22%
1/452 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/220 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/526 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/452 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.00%
0/451 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
0.45%
1/220 • Number of events 1 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
Other adverse events
| Measure |
GFF MDI (PT003)
n=526 participants at risk
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
|
GP MDI (PT001)
n=451 participants at risk
Glycopyrronium (GP) MDI 14.4 mcg
|
FF MDI (PT005)
n=452 participants at risk
Formoterol Fumarate (FF) MDI 9.6 mcg
|
Spiriva® Handihaler® (Open-label)
n=451 participants at risk
Open-label tiotropium bromide inhalation powder 18 mcg
|
Placebo
n=220 participants at risk
Placebo MDI
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.2%
43/526 • Number of events 45 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
5.1%
23/451 • Number of events 24 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
6.2%
28/452 • Number of events 32 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
5.8%
26/451 • Number of events 26 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
8.2%
18/220 • Number of events 21 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
17/526 • Number of events 18 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
4.4%
20/451 • Number of events 21 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.1%
14/452 • Number of events 14 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.8%
17/451 • Number of events 18 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
7.3%
16/220 • Number of events 16 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
13/526 • Number of events 13 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.5%
16/451 • Number of events 19 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.3%
15/452 • Number of events 16 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
3.3%
15/451 • Number of events 15 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
5.9%
13/220 • Number of events 14 • SAEs and AEs were collected throughout study participation and for two weeks after study completion.
Safety population included all participants who received at least one dose of investigational drug participants were included in safety population according to the investigational drug received
|
Additional Information
Colin Reisner, MD, FCCP, FAAAAI
Pearl Therapeutics, Inc
Phone: 973-975-0320
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER