Trial Outcomes & Findings for Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC) (NCT NCT03285321)

NCT ID: NCT03285321

Last Updated: 2026-01-20

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as the time from randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 105 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2026-01-20

Participant Flow

Participant milestones

Measure	Arm 1: Nivolumab Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
Overall Study STARTED	54	51
Overall Study COMPLETED	54	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Arm 1: Nivolumab n=54 Participants Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 Participants Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg	Total n=105 Participants Total of all reporting groups
Age, Continuous	65 years n=37 Participants	63 years n=44 Participants	64 years n=40 Participants
Sex: Female, Male Female	30 Participants n=37 Participants	22 Participants n=44 Participants	52 Participants n=40 Participants
Sex: Female, Male Male	24 Participants n=37 Participants	29 Participants n=44 Participants	53 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	1 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Asian	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	10 Participants n=37 Participants	16 Participants n=44 Participants	26 Participants n=40 Participants
Race (NIH/OMB) White	42 Participants n=37 Participants	30 Participants n=44 Participants	72 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	1 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	3 Participants n=44 Participants	4 Participants n=40 Participants
Region of Enrollment United States	54 participants n=37 Participants	51 participants n=44 Participants	105 participants n=40 Participants
ECOG Performance Status ECOG = 0	18 Participants n=37 Participants	27 Participants n=44 Participants	45 Participants n=40 Participants
ECOG Performance Status ECOG = 1	36 Participants n=37 Participants	24 Participants n=44 Participants	60 Participants n=40 Participants

PRIMARY outcome

Timeframe: 18 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.

PFS is defined as the time from randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.

Outcome measures

Measure	Arm 1: Nivolumab n=54 Participants Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 Participants Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
Progression Free Survival (PFS) at 18-month	65.5 Percentage of participants Interval 49.8 to 77.3	66.3 Percentage of participants Interval 56.3 to 74.5

SECONDARY outcome

Timeframe: 4 years

Overall survival is defined as the time from randomization until death from any cause.

Outcome measures

Measure	Arm 1: Nivolumab n=54 Participants Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 Participants Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
Overall Survival (OS)	32 Months Interval 32.0 to Not enough events occur to calculate the upper 95% confidence interval.	NA Months Interval 30.9 to Not enough events occur to calculate the median and upper 95% confidence interval.

SECONDARY outcome

Timeframe: 36 Months

TTMD is defined as the time from randomization until evidence of disease outside of the radiated field. The estimate of TTMD at 36 month with 95% confidence interval are reported in the outcome measure data.

Outcome measures

Measure	Arm 1: Nivolumab n=54 Participants Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 Participants Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
Time to Metastatic Disease (TTMD) at 36 Month	79.7 Percentage of participants Interval 61.0 to 90.1	77.5 Percentage of participants Interval 58.2 to 88.7

SECONDARY outcome

Timeframe: Up to 12 months

Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Measure	Arm 1: Nivolumab n=54 Participants Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 Participants Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
Number of Participants With Adverse Events	54 Participants	51 Participants

Adverse Events

Arm 1: Nivolumab

Serious events: 10 serious events

Other events: 52 other events

Deaths: 14 deaths

Arm 2: Nivolumab Plus Ipilimumab

Serious events: 21 serious events

Other events: 51 other events

Deaths: 15 deaths

Serious adverse events

Measure	Arm 1: Nivolumab n=54 participants at risk Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 participants at risk Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
CARDIAC DISORDERS ATRIAL FIBRILLATION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS CHEST PAIN - CARDIAC	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS HEART FAILURE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS LUNG INFECTION	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS NON-CARDIAC CHEST PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PNEUMONITIS	9.3% 5/54 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	17.6% 9/51 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS SEPSIS	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS SINUS TACHYCARDIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
VASCULAR DISORDERS THROMBOEMBOLIC EVENT	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS URTICARIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS BRONCHOPULMONARY HEMORRHAGE	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS CARDIAC ARREST	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS COGNITIVE DISTURBANCE	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS COLITIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS DEHYDRATION	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FEVER	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCEMIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPONATREMIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HYPOXIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
IMMUNE SYSTEM DISORDERS IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS MYOCARDIAL INFARCTION	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS PANCREATITIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY FAILURE	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.

Other adverse events

Measure	Arm 1: Nivolumab n=54 participants at risk Nivolumab 480mg IV every 4 weeks for up to 6 cycles Nivolumab: 480mg	Arm 2: Nivolumab Plus Ipilimumab n=51 participants at risk Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab) Nivolumab: 240mg Ipilimumab: 1mg/kg
PSYCHIATRIC DISORDERS AGITATION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS ALANINE AMINOTRANSFERASE INCREASED	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS ALKALINE PHOSPHATASE INCREASED	3.7% 2/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS ALLERGIC RHINITIS	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ALOPECIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS LIPASE INCREASED	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
BLOOD AND LYMPHATIC SYSTEM DISORDERS ANEMIA	11.1% 6/54 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	25.5% 13/51 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS ANKLE FRACTURE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS ANOREXIA	11.1% 6/54 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	15.7% 8/51 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
PSYCHIATRIC DISORDERS ANXIETY	7.4% 4/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA	5.6% 3/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	13.7% 7/51 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRITIS	3.7% 2/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS ASPARTATE AMINOTRANSFERASE INCREASED	5.6% 3/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS WEIGHT LOSS	9.3% 5/54 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	17.6% 9/51 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS ACUTE CORONARY SYNDROME	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS ATRIAL FIBRILLATION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BACK PAIN	14.8% 8/54 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	13.7% 7/51 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS BLADDER INFECTION	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
BLOOD AND LYMPHATIC SYSTEM DISORDERS BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EYE DISORDERS BLURRED VISION	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS BRONCHIAL INFECTION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS BRONCHOSPASM	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS BRUISING	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS BULLOUS DERMATITIS	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS CARDIAC DISORDERS - OTHER, SPECIFY	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS CHEST WALL PAIN	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHILLS	3.7% 2/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS CHOLESTEROL HIGH	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
PSYCHIATRIC DISORDERS CONFUSION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS CONSTIPATION	9.3% 5/54 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	13.7% 7/51 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS COUGH	29.6% 16/54 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	47.1% 24/51 • Number of events 29 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS CREATININE INCREASED	11.1% 6/54 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	9.8% 5/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS DEHYDRATION	7.4% 4/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS DENTAL CARIES	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
PSYCHIATRIC DISORDERS DEPRESSION	5.6% 3/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS DIARRHEA	16.7% 9/54 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	31.4% 16/51 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS DIZZINESS	18.5% 10/54 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	19.6% 10/51 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS DRY MOUTH	7.4% 4/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS DRY SKIN	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS DYSGEUSIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS DYSPHAGIA	7.4% 4/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS DYSPHASIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	33.3% 18/54 • Number of events 23 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	47.1% 24/51 • Number of events 46 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EAR AND LABYRINTH DISORDERS EAR PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS EDEMA LIMBS	9.3% 5/54 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	13.7% 7/51 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
ENDOCRINE DISORDERS ENDOCRINE DISORDERS - OTHER, SPECIFY	5.6% 3/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS ERECTILE DYSFUNCTION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ERYTHEMA MULTIFORME	1.9% 1/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS ESOPHAGEAL ULCER	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS ESOPHAGITIS	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EYE DISORDERS EYE DISORDERS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FALL	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FATIGUE	40.7% 22/54 • Number of events 35 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	49.0% 25/51 • Number of events 40 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FEVER	9.3% 5/54 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS FLANK PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS FLATULENCE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS GASTROESOPHAGEAL REFLUX DISEASE	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	7.4% 4/54 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	15.7% 8/51 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS GUM INFECTION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS HEADACHE	22.2% 12/54 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	31.4% 16/51 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EAR AND LABYRINTH DISORDERS HEARING IMPAIRED	1.9% 1/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RENAL AND URINARY DISORDERS HEMATURIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HOARSENESS	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCEMIA	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS HYPERHIDROSIS	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPERKALEMIA	1.9% 1/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
VASCULAR DISORDERS HYPERTENSION	5.6% 3/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
ENDOCRINE DISORDERS HYPERTHYROIDISM	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPOKALEMIA	13.0% 7/54 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	17.6% 9/51 • Number of events 17 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPOMAGNESEMIA	16.7% 9/54 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPONATREMIA	7.4% 4/54 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	9.8% 5/51 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPOPHOSPHATEMIA	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
VASCULAR DISORDERS HYPOTENSION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
ENDOCRINE DISORDERS HYPOTHYROIDISM	20.4% 11/54 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	17.6% 9/51 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
PSYCHIATRIC DISORDERS INSOMNIA	7.4% 4/54 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	19.6% 10/51 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS JOINT EFFUSION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS LARYNGITIS	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
PSYCHIATRIC DISORDERS LIBIDO DECREASED	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS LUNG INFECTION	16.7% 9/54 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	19.6% 10/51 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS LYMPHOCYTE COUNT DECREASED	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS MEMORY IMPAIRMENT	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCLE WEAKNESS LOWER LIMB	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	9.3% 5/54 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MYALGIA	9.3% 5/54 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MYOSITIS	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS NASAL CONGESTION	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	13.7% 7/51 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS NAUSEA	24.1% 13/54 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	29.4% 15/51 • Number of events 25 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS NECK PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS NEUTROPHIL COUNT DECREASED	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS NON-CARDIAC CHEST PAIN	16.7% 9/54 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	9.8% 5/51 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS ORAL PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PAIN	18.5% 10/54 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	21.6% 11/51 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN EXTREMITY	7.4% 4/54 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	13.7% 7/51 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS PERIPHERAL SENSORY NEUROPATHY	11.1% 6/54 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PNEUMONITIS	18.5% 10/54 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	29.4% 15/51 • Number of events 25 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PNEUMOTHORAX	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PRODUCTIVE COUGH	11.1% 6/54 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS	14.8% 8/54 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	27.5% 14/51 • Number of events 25 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH ACNEIFORM	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH MACULO-PAPULAR	18.5% 10/54 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	23.5% 12/51 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS RECTAL HEMORRHAGE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RENAL AND URINARY DISORDERS RENAL AND URINARY DISORDERS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY FAILURE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	13.0% 7/54 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EYE DISORDERS RETINOPATHY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS RHINITIS INFECTIVE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS SINUS TACHYCARDIA	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS SINUSITIS	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	13.0% 7/54 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	15.7% 8/51 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN HYPOPIGMENTATION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS SKIN INFECTION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SORE THROAT	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS SPINAL FRACTURE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SURGICAL AND MEDICAL PROCEDURES SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS SYNCOPE	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
VASCULAR DISORDERS THROMBOEMBOLIC EVENT	7.4% 4/54 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	9.8% 5/51 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS UPPER RESPIRATORY INFECTION	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	11.8% 6/51 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS URINARY TRACT INFECTION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RENAL AND URINARY DISORDERS URINARY TRACT PAIN	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RENAL AND URINARY DISORDERS URINARY URGENCY	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS URTICARIA	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS VAGINAL INFECTION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS VOMITING	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	17.6% 9/51 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS WEIGHT GAIN	5.6% 3/54 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS WHEEZING	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS WHITE BLOOD CELL DECREASED	3.7% 2/54 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS WOUND COMPLICATION	1.9% 1/54 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	0.00% 0/51 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS ABDOMINAL INFECTION	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
ENDOCRINE DISORDERS ADRENAL INSUFFICIENCY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BONE PAIN	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS BREAST PAIN	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS CHEST PAIN - CARDIAC	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS COLITIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EYE DISORDERS CONJUNCTIVITIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS DYSPEPSIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS EPISTAXIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	7.8% 4/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FACIAL PAIN	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GAIT DISTURBANCE	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS GASTRITIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS GENERALIZED MUSCLE WEAKNESS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
VASCULAR DISORDERS HOT FLASHES	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
METABOLISM AND NUTRITION DISORDERS HYPOALBUMINEMIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HYPOXIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
IMMUNE SYSTEM DISORDERS IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS INVESTIGATIONS - OTHER, SPECIFY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
BLOOD AND LYMPHATIC SYSTEM DISORDERS LEUKOCYTOSIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS LOCALIZED EDEMA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS PAPULOPUSTULAR RASH	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS PARESTHESIA	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
CARDIAC DISORDERS PERICARDIAL EFFUSION	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS PLATELET COUNT DECREASED	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	9.8% 5/51 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS POSTNASAL DRIP	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS PRESYNCOPE	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PULMONARY FIBROSIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PULMONARY HYPERTENSION	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INFECTIONS AND INFESTATIONS SEPSIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
INVESTIGATIONS SERUM AMYLASE INCREASED	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	5.9% 3/51 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS SINUS PAIN	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
GASTROINTESTINAL DISORDERS STOMACH PAIN	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
VASCULAR DISORDERS SUPERFICIAL THROMBOPHLEBITIS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EAR AND LABYRINTH DISORDERS TINNITUS	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
NERVOUS SYSTEM DISORDERS TREMOR	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
RENAL AND URINARY DISORDERS URINARY FREQUENCY	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	3.9% 2/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
EAR AND LABYRINTH DISORDERS VERTIGO	0.00% 0/54 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.	2.0% 1/51 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 4 Years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: fsharmin@hoosiercancer.org

Results disclosure agreements

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