Trial Outcomes & Findings for Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2) (NCT NCT01854658)
NCT ID: NCT01854658
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
1615 participants
Primary outcome timeframe
At Week 24
Results posted on
2017-03-28
Participant Flow
Conducted at 140 sites throughout the United States from July 2013 - February 2015. Study participation was a maximum of 32 weeks.
A multicenter, randomized, double-blind, parallel group, chronic dosing, active- and placebo-controlled study; each participant was randomized to receive 1 of 4 possible treatments over the course of a 24-week treatment period (With a randomization of 7:6:6:3 GFF MDI, GP MDI, FF MDI and Placebo MDI)
Participant milestones
| Measure |
FF MDI (PT005)
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
439
|
440
|
512
|
224
|
|
Overall Study
COMPLETED
|
346
|
365
|
432
|
165
|
|
Overall Study
NOT COMPLETED
|
93
|
75
|
80
|
59
|
Reasons for withdrawal
| Measure |
FF MDI (PT005)
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
2
|
2
|
1
|
|
Overall Study
Physician Decision
|
7
|
5
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
28
|
21
|
29
|
15
|
|
Overall Study
Protocol-specified criteria
|
15
|
15
|
10
|
7
|
|
Overall Study
Lack of Efficacy
|
3
|
8
|
4
|
7
|
|
Overall Study
Adverse Event
|
21
|
14
|
23
|
19
|
|
Overall Study
Administrative reasons
|
5
|
1
|
2
|
2
|
Baseline Characteristics
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
Baseline characteristics by cohort
| Measure |
FF MDI (PT005)
n=437 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=439 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=510 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=223 Participants
Inhaled placebo administered as two puffs BID
|
Total
n=1609 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
62.8 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
62.8 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
62.9 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
723 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
247 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
886 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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 |
FF MDI (PT005)
n=350 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=367 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=433 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=170 Participants
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1
|
0.061 Liters
Interval 0.039 to 0.082
|
0.063 Liters
Interval 0.041 to 0.084
|
0.116 Liters
Interval 0.097 to 0.136
|
0.013 Liters
Interval -0.018 to 0.044
|
SECONDARY outcome
Timeframe: Over 24 weeksPopulation: 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 model-based 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 |
FF MDI (PT005)
n=434 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=434 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=503 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=216 Participants
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
|
0.080 Liters
Interval 0.064 to 0.095
|
0.082 Liters
Interval 0.067 to 0.097
|
0.137 Liters
Interval 0.123 to 0.151
|
0.008 Liters
Interval -0.014 to 0.03
|
SECONDARY outcome
Timeframe: At week 24Population: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24
Outcome measures
| Measure |
FF MDI (PT005)
n=346 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=365 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=431 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=165 Participants
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Peak FEV1
|
0.268 Liters
Interval 0.244 to 0.292
|
0.223 Liters
Interval 0.199 to 0.247
|
0.350 Liters
Interval 0.328 to 0.371
|
0.083 Liters
Interval 0.048 to 0.117
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Change from baseline in the SGRQ total score at Week 24. 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 |
FF MDI (PT005)
n=352 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=362 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=430 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=170 Participants
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
St. George Respiratory Questionnaire (SGRQ) Score
|
-2.3 Scores on a scale
Interval -3.5 to -1.1
|
-2.2 Scores on a scale
Interval -3.4 to -1.0
|
-3.0 Scores on a scale
Interval -4.1 to -1.8
|
-1.2 Scores on a scale
Interval -3.0 to 0.5
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Outcome measures
| Measure |
FF MDI (PT005)
n=437 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=438 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=510 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=223 Participants
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Rescue Ventolin HFA Use
|
-0.7 Puffs / Day
Interval -0.9 to -0.5
|
-0.4 Puffs / Day
Interval -0.6 to -0.3
|
-1.0 Puffs / Day
Interval -1.2 to -0.8
|
0.0 Puffs / Day
Interval -0.2 to 0.3
|
SECONDARY outcome
Timeframe: 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 |
FF MDI (PT005)
n=375 Participants
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=371 Participants
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=429 Participants
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=179 Participants
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Onset of Action as Assessed by FEV1
15 min post dose
|
0.212 Liters
Interval 0.199 to 0.225
|
0.109 Liters
Interval 0.096 to 0.122
|
0.237 Liters
Interval 0.225 to 0.249
|
0.022 Liters
Interval 0.003 to 0.04
|
|
Onset of Action as Assessed by FEV1
5 min post dose
|
0.175 Liters
Interval 0.163 to 0.188
|
0.052 Liters
Interval 0.04 to 0.065
|
0.192 Liters
Interval 0.18 to 0.204
|
0.006 Liters
Interval -0.012 to 0.024
|
Adverse Events
FF MDI (PT005)
Serious events: 37 serious events
Other events: 21 other events
Deaths: 0 deaths
GP MDI (PT001)
Serious events: 37 serious events
Other events: 12 other events
Deaths: 0 deaths
GFF MDI (PT003)
Serious events: 36 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo MDI
Serious events: 15 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF MDI (PT005)
n=438 participants at risk
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=439 participants at risk
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=510 participants at risk
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=223 participants at risk
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
8/438 • Number of events 8 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
2.1%
9/439 • Number of events 9 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
1.6%
8/510 • Number of events 8 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
1.8%
4/223 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.46%
2/438 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.90%
2/223 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.59%
3/510 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered 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%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Pneumonia
|
0.91%
4/438 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.91%
4/439 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.39%
2/510 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
1.3%
3/223 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Sepsis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Bronchitis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Extradural abscess
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Septic shock
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Infections and infestations
Urosepsis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.46%
2/439 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.59%
3/510 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.46%
2/439 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.90%
2/223 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrioventricular block
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered 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
|
0.46%
2/438 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered 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
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.39%
2/510 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.46%
2/439 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.46%
2/438 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Ileus
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
General disorders
Chest pain
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
General disorders
Non-cardiac chest pain
|
0.46%
2/438 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
General disorders
Death
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
General disorders
Chest discomfort
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Hypertension
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.46%
2/439 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.39%
2/510 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Aortic aneurysm
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Hypotension
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Syncope
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.46%
2/439 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Convulsion
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Dizziness
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Presyncope
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Sciatica
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.20%
1/510 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Alcoholism
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.45%
1/223 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.23%
1/438 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/439 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/438 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.23%
1/439 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/510 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
0.00%
0/223 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
Other adverse events
| Measure |
FF MDI (PT005)
n=438 participants at risk
FF MDI 9.6 mcg administered as two puffs BID
|
GP MDI (PT001)
n=439 participants at risk
GP MDI 14.4 mcg administered as two puffs BID
|
GFF MDI (PT003)
n=510 participants at risk
GFF MDI 14.4/9.6 mcg administered as two puffs BID
|
Placebo MDI
n=223 participants at risk
Inhaled placebo administered as two puffs BID
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.8%
21/438 • Number of events 21 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
2.7%
12/439 • Number of events 12 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
4.3%
22/510 • Number of events 22 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
|
4.5%
10/223 • Number of events 13 • Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Safety population included all participants who were administered 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