Trial Outcomes & Findings for Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) (NCT NCT01488019)

NCT ID: NCT01488019

Last Updated: 2017-06-12

Results Overview

The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1071 participants
• Primary outcome timeframe: 0 to 52 weeks
• Results posted on: 2017-06-12

Participant Flow

Participant milestones

Measure	Perforomist Inhalation Solution Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Overall Study STARTED	541	530
Overall Study COMPLETED	294	226
Overall Study NOT COMPLETED	247	304

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only subjects with data collected and valid measurements included

Baseline characteristics by cohort

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks	Total n=1071 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 9.01 • n=541 Participants	62.5 years STANDARD_DEVIATION 9.17 • n=530 Participants	62.6 years STANDARD_DEVIATION 9.09 • n=1071 Participants
Sex: Female, Male Female	285 Participants n=541 Participants	267 Participants n=530 Participants	552 Participants n=1071 Participants
Sex: Female, Male Male	256 Participants n=541 Participants	263 Participants n=530 Participants	519 Participants n=1071 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=541 Participants	26 Participants n=530 Participants	55 Participants n=1071 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	512 Participants n=541 Participants	504 Participants n=530 Participants	1016 Participants n=1071 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=541 Participants	0 Participants n=530 Participants	0 Participants n=1071 Participants
Race/Ethnicity, Customized White	483 Participants n=541 Participants	478 Participants n=530 Participants	961 Participants n=1071 Participants
Race/Ethnicity, Customized Black or African American	51 Participants n=541 Participants	46 Participants n=530 Participants	97 Participants n=1071 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=541 Participants	2 Participants n=530 Participants	2 Participants n=1071 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=541 Participants	1 Participants n=530 Participants	5 Participants n=1071 Participants
Race/Ethnicity, Customized Other	3 Participants n=541 Participants	3 Participants n=530 Participants	6 Participants n=1071 Participants
Region of Enrollment United States	541 Participants n=541 Participants	530 Participants n=530 Participants	1071 Participants n=1071 Participants
Screening COPD Severity (GOLD) n (%) Moderate (% Predicted FEV1 50 to <80%)	274 Participants n=541 Participants	273 Participants n=530 Participants	547 Participants n=1071 Participants
Screening COPD Severity (GOLD) n (%) Severe (% Predicted FEV1 30 to <50%)	261 Participants n=541 Participants	250 Participants n=530 Participants	511 Participants n=1071 Participants
Screening COPD Severity (GOLD) n (%) Very Severe (% Predicted FEV1 <30%)	3 Participants n=541 Participants	4 Participants n=530 Participants	7 Participants n=1071 Participants
Screening COPD Severity (GOLD) n (%) Not Reported/Unknown	3 Participants n=541 Participants	3 Participants n=530 Participants	6 Participants n=1071 Participants
Baseline FEV1	1.2494 Litres STANDARD_DEVIATION 0.47593 • n=539 Participants • Only subjects with data collected and valid measurements included	1.2926 Litres STANDARD_DEVIATION 0.50496 • n=526 Participants • Only subjects with data collected and valid measurements included	1.2707 Litres STANDARD_DEVIATION 0.49073 • n=1065 Participants • Only subjects with data collected and valid measurements included
Baseline % Predicted FEV1	43.82 % STANDARD_DEVIATION 12.646 • n=539 Participants • Only subjects with data collected and valid measurements included	44.89 % STANDARD_DEVIATION 13.787 • n=526 Participants • Only subjects with data collected and valid measurements included	44.35 % STANDARD_DEVIATION 13.226 • n=1065 Participants • Only subjects with data collected and valid measurements included
Baseline FVC	2.4276 Litres STANDARD_DEVIATION 0.74347 • n=539 Participants • Only subjects with data collected and valid measurements included	2.4740 Litres STANDARD_DEVIATION 0.78394 • n=526 Participants • Only subjects with data collected and valid measurements included	2.451 Litres STANDARD_DEVIATION 0.76373 • n=1065 Participants • Only subjects with data collected and valid measurements included
Baseline IC	1.9458 Litres STANDARD_DEVIATION 0.66598 • n=522 Participants • Only subjects with data collected and valid measurements included	1.9783 Litres STANDARD_DEVIATION 0.66897 • n=514 Participants • Only subjects with data collected and valid measurements included	1.9619 Litres STANDARD_DEVIATION 0.66734 • n=1036 Participants • Only subjects with data collected and valid measurements included
Number of Pack Years	41 Pack Years n=541 Participants	44.00 Pack Years n=530 Participants	43.00 Pack Years n=1071 Participants
Smoking Status n (%) Ex-smoker	259 Participants n=541 Participants	252 Participants n=530 Participants	511 Participants n=1071 Participants
Smoking Status n (%) Current Smoker	282 Participants n=541 Participants	278 Participants n=530 Participants	560 Participants n=1071 Participants
Baseline Saint Georges Respiratory Questionnaire Score	53.429 units on a scale STANDARD_DEVIATION 16.9607 • n=536 Participants • Only subjects with data collected and valid measurements included	52.550 units on a scale STANDARD_DEVIATION 16.9953 • n=529 Participants • Only subjects with data collected and valid measurements included	52.992 units on a scale STANDARD_DEVIATION 16.9756 • n=1065 Participants • Only subjects with data collected and valid measurements included
Baseline Dyspnea Index	6.1 units on a scale STANDARD_DEVIATION 1.99 • n=539 Participants • Only subjects with data collected and valid measurements included	6.2 units on a scale STANDARD_DEVIATION 1.99 • n=528 Participants • Only subjects with data collected and valid measurements included	6.2 units on a scale STANDARD_DEVIATION 1.99 • n=1067 Participants • Only subjects with data collected and valid measurements included

PRIMARY outcome

Timeframe: 0 to 52 weeks

Population: Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation	64 Participants	57 Participants

PRIMARY outcome

Timeframe: 0 to 52 weeks

Population: Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks	15.5 percent	14.9 percent

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality Incidence of All Cause Mortalities	3 Participants	10 Participants
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality Incidence of Respiratory Related Mortalities	0 Participants	1 Participants
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality Incidence of COPD Related Mortalities	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization Subjects with a COPD- related ER Visit	46 Participants	47 Participants
Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization Subjects with a COPD-Related Hospitalization	39 Participants	43 Participants

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication. The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Number of Subjects With Protocol-Defined COPD Exacerbation	142 Participants	135 Participants

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks	34.7 percent	34.0 percent

SECONDARY outcome

Timeframe: On treatment at months 3, 6, 9 and 12

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
FEV1 Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FEV1: Month 3	0.058 Litres Standard Error 0.0116	0.016 Litres Standard Error 0.0123
FEV1 Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FEV1: Month 6	0.057 Litres Standard Error 0.0130	0.017 Litres Standard Error 0.0143
FEV1 Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FEV1: Month 9	0.050 Litres Standard Error 0.0136	0.029 Litres Standard Error 0.0151
FEV1 Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FEV1: Month 12	0.030 Litres Standard Error 0.0144	0.000 Litres Standard Error 0.0160

SECONDARY outcome

Timeframe: On treatment at months 3, 6, 9 and 12

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
FVC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FVC: Month 9	0.1009 Litres Standard Deviation 0.39533	-0.0254 Litres Standard Deviation 0.40947
FVC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FVC: Month 3	0.1051 Litres Standard Deviation 0.40479	0.0062 Litres Standard Deviation 0.38724
FVC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FVC: Month 6	0.1006 Litres Standard Deviation 0.38875	-0.0241 Litres Standard Deviation 0.37124
FVC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline FVC: Month 12	0.0645 Litres Standard Deviation 0.43490	-0.0581 Litres Standard Deviation 0.38069

SECONDARY outcome

Timeframe: On treatment at months 3, 6, 9 and 12

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
IC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline IC: Month 3	0.0287 Litres Standard Deviation 0.42478	-0.0119 Litres Standard Deviation 0.39505
IC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline IC: Month 6	0.0440 Litres Standard Deviation 0.44862	-0.0106 Litres Standard Deviation 0.43483
IC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline IC: Month 9	0.1584 Litres Standard Deviation 1.84290	-0.0118 Litres Standard Deviation 0.43513
IC Changes From Baseline at Months 3, 6, 9 and 12 Change from Baseline IC: Month 12	0.0477 Litres Standard Deviation 0.48057	-0.0105 Litres Standard Deviation 0.44289

SECONDARY outcome

Timeframe: On treatment at months 3, 6, 9 and 12

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected were included

Saint Georges Respiratory Questionnaire comprises 50 items in 3 sections, Symptoms, Activity, Impact, measuring health status in chronic airflow limitation. Symptoms captures level of symptomatology. Activity and Impact responses are either "yes" or "no". Scoring is from 0 to 100; 0 = no life quality impairment. A summary score for all items is calculated and ranges from 0 to 100, where 0 indicates best possible health status, 100 represents worst possible health status. Scores are calculated using weights attached to each item in the questionnaire - 4 unit changes are clinically meaningful.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12 Change from Baseline SGRQ Total Score: Month 3	-3.252 units on a scale Standard Error 0.5472	-2.027 units on a scale Standard Error 0.5727
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12 Change from Baseline SGRQ Total Score: Month 6	-2.329 units on a scale Standard Error 0.6541	-2.511 units on a scale Standard Error 0.7156
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12 Change from Baseline SGRQ Total Score: Month 9	-2.021 units on a scale Standard Error 0.7022	-2.115 units on a scale Standard Error 0.7681
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12 Change from Baseline SGRQ Total Score: Month 12	-1.453 units on a scale Standard Error 0.7559	-1.475 units on a scale Standard Error 0.8345

SECONDARY outcome

Timeframe: On treatment at months 3, 6, 9 and 12

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.

The Transition Dyspnea Index (TDI) measures changes in dyspnea severity from the baseline as established by the BDI. It has 3 components: change in functional impairment, change in magnitude of task, and change in magnitude of effort, and each component is rated on a scale ranging from -3 (major deterioration) to +3 (major improvement). The 3 components are summed to provide a total score ranging from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Transition Dyspnea Index Month 3	0.7 units on a scale Standard Error 0.11	0.0 units on a scale Standard Error 0.12
Transition Dyspnea Index Month 6	0.5 units on a scale Standard Error 0.13	0.4 units on a scale Standard Error 0.14
Transition Dyspnea Index Month 9	0.7 units on a scale Standard Error 0.14	0.4 units on a scale Standard Error 0.15
Transition Dyspnea Index Month 12	0.5 units on a scale Standard Error 0.14	0.6 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Health Care Utilization and Economic Impact - Number of Emergency Department Visits >=3	1 Participants	2 Participants
Health Care Utilization and Economic Impact - Number of Emergency Department Visits 0	447 Participants	437 Participants
Health Care Utilization and Economic Impact - Number of Emergency Department Visits 1	78 Participants	75 Participants
Health Care Utilization and Economic Impact - Number of Emergency Department Visits 2	15 Participants	16 Participants

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Summary of Subjects Requiring Intubation or Non-Invasive Ventilation	3 Participants	10 Participants

SECONDARY outcome

Timeframe: 0 to 52 weeks

Population: Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.

Number of puffs of rescue medication (albuterol pMDI) used per day

Outcome measures

Measure	Perforomist Inhalation Solution n=541 Participants Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 Participants Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Rescue Medication Usage Baseline	2.55 Mean Puffs per Day Standard Deviation 2.496	2.52 Mean Puffs per Day Standard Deviation 2.484
Rescue Medication Usage Treatment Phase	1.92 Mean Puffs per Day Standard Deviation 2.063	2.35 Mean Puffs per Day Standard Deviation 2.521

Adverse Events

Perforomist Inhalation Solution

Serious events: 86 serious events

Other events: 374 other events

Deaths: 3 deaths

Matching Placebo

Serious events: 85 serious events

Other events: 369 other events

Deaths: 10 deaths

Serious adverse events

Measure	Perforomist Inhalation Solution n=541 participants at risk Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 participants at risk Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Respiratory, thoracic and mediastinal disorders COPD	7.2% 39/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	7.5% 40/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.1% 6/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.1% 6/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Acute Myocardial Infarction	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.1% 6/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Pneumonia	1.8% 10/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.9% 10/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Lobar Pneumonia	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.1% 6/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Blood and lymphatic system disorders Haemorrhagic anaemia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Coronary artery disease	0.55% 3/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.57% 3/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Atrial fibrillation	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Cardiac arrest	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.57% 3/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Cardiac failure congestive	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.57% 3/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Supraventricular tachycardia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Ventricular fibrillation	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Atrioventricular block complete	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Cardiomyopathy	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Coronary artery occlusion	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Left ventricular dysfunction	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Cardiac disorders Myocardial infarction	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Endocrine disorders Hyperthyroidism	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Eye disorders Optic ischaemic neuropathy	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Eye disorders Papilloedema	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Intestinal ischaemia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Small intestinal obstruction	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Abdominal pain	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Colitis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Dysphagia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Inguinal hernia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Nausea	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Vomiting	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
General disorders Chest pain	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.57% 3/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
General disorders Non-cardiac chest pain	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
General disorders Systemic inflammatory response syndrome	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Hepatobiliary disorders Cholelithiasis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Sepsis	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.75% 4/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Influenza	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Septic shock	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.57% 3/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Bronchitis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Cellulitis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Pyelonephritis	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Abscess	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Appendicitis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Bronchitis bacterial	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Bronchitis pneumococcal	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Diverticulitis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Gallbladder abscess	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Groin abscess	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Liver abscess	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Osteomyelitis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Pneumonia klebsiella	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Pneumonia legionella	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Pyelonephritis acute	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Urinary tract infection	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Rib fracture	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Pneumothorax traumatic	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Alcohol poisoning	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Pelvic fracture	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Metabolism and nutrition disorders Hypokalaemia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Metabolism and nutrition disorders Hypercalcaemia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Metabolism and nutrition disorders Hypomagnesaemia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Muscle spasms	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage III	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Syncope	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.57% 3/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Thalamic infarction	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Basal ganglia infarction	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Carotid artery stenosis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Cervicobrachial syndrome	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Embolic stroke	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Encephalopathy	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Ischaemic stroke	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Migraine	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Multiple sclerosis	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Spondylitic myelopathy	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Psychiatric disorders Depression	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Psychiatric disorders Mental status changes	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Psychiatric disorders Alcohol abuse	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Psychiatric disorders Hallucination	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Renal and urinary disorders Renal failure acute	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.75% 4/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Renal and urinary disorders Renal failure	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Renal and urinary disorders Bladder outlet obstruction	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Renal and urinary disorders Renal failure chronic	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Renal and urinary disorders Stress urinary incontinence	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Reproductive system and breast disorders Penile necrosis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Reproductive system and breast disorders Priapism	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.38% 2/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 2/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Deep vein thrombosis	0.55% 3/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Hypertension	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Hypotension	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Iliac artery occlusion	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Peripheral ischaemia	0.18% 1/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.00% 0/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Peripheral vascular disorder	0.00% 0/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	0.19% 1/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)

Other adverse events

Measure	Perforomist Inhalation Solution n=541 participants at risk Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks	Matching Placebo n=530 participants at risk Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks
Infections and infestations Upper Respiratory Tract Infection	6.7% 36/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	6.0% 32/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Bronchitis	6.3% 34/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	4.9% 26/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders COPD	30.3% 164/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	27.4% 145/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Dyspnea	6.5% 35/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	7.5% 40/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Cough	7.2% 39/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	4.5% 24/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Nausea	3.3% 18/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.3% 7/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Diarrhea	2.4% 13/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	2.1% 11/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Gastrointestinal disorders Constipation	2.0% 11/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.1% 6/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Nasopharyngitis	4.4% 24/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	3.4% 18/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Sinusitis	4.6% 25/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	2.3% 12/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Pneumonia	3.3% 18/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	3.4% 18/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Urinary Tract Infection	2.6% 14/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	2.5% 13/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Infections and infestations Influenza	2.0% 11/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.5% 8/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Back Pain	2.2% 12/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.7% 9/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Musculoskeletal and connective tissue disorders Muscle Spasms	2.2% 12/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.5% 8/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Nervous system disorders Headache	3.9% 21/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	4.2% 22/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Psychiatric disorders Anxiety	2.2% 12/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.3% 7/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.1% 6/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	2.1% 11/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)
Vascular disorders Hypertension	2.4% 13/541 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)	1.5% 8/530 • Approximately 14 months (date of signature of the Informed Consent Form to 30 days after last dose of study drug) Subject Deaths during the Study: Perforomist x3 (Neoplasms x2, Cardiac Disorders x1) Placebo x10 (Respiratory, Thoracic and Mediastinal Disorders x1, Neoplasms x2, Cardiac Disorders x5, Infections and Infestations x1, Injury x1)

Additional Information

Dik Ng, PhD, Director Clinical Science

Mylan UK

Phone: +44 1304626895

Email: dik.ng@mylan.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place