Trial Outcomes & Findings for Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948) (NCT NCT00090259)

Participant milestones
Measure	Losartan 50 mg	Losartan 150 mg
Overall Study STARTED	1913	1921
Overall Study COMPLETED	1851	1873
Overall Study NOT COMPLETED	62	48

Reasons for withdrawal
Measure	Losartan 50 mg	Losartan 150 mg
Overall Study Lost to Follow-up	30	26
Overall Study Withdrawal by Subject	21	15
Overall Study Investigator site closed	11	7

Baseline characteristics by cohort
Measure	Losartan 50 mg n=1913 Participants	Losartan 150 mg n=1921 Participants	Total n=3834 Participants Total of all reporting groups
Age, Continuous	64.1 years n=5 Participants	64.4 years n=7 Participants	64.2 years n=5 Participants
Age, Customized < 65 years of Age	889 participants n=5 Participants	879 participants n=7 Participants	1768 participants n=5 Participants
Age, Customized >=65 years of Age	1024 participants n=5 Participants	1042 participants n=7 Participants	2066 participants n=5 Participants
Sex: Female, Male Female	560 Participants n=5 Participants	583 Participants n=7 Participants	1143 Participants n=5 Participants
Sex: Female, Male Male	1353 Participants n=5 Participants	1338 Participants n=7 Participants	2691 Participants n=5 Participants
Angiotensin II antagonists No	456 Participants n=5 Participants	438 Participants n=7 Participants	894 Participants n=5 Participants
Angiotensin II antagonists Yes	1457 Participants n=5 Participants	1483 Participants n=7 Participants	2940 Participants n=5 Participants
New York Heart Association (NYHA) functional status I No symptoms	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
New York Heart Association (NYHA) functional status II Mild symptoms	1330 Participants n=5 Participants	1327 Participants n=7 Participants	2657 Participants n=5 Participants
New York Heart Association (NYHA) functional status III Marked limitation	569 Participants n=5 Participants	583 Participants n=7 Participants	1152 Participants n=5 Participants
New York Heart Association (NYHA) functional status IV Severe limitations	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region Asia and Pacific Region	391 participants n=5 Participants	390 participants n=7 Participants	781 participants n=5 Participants
Region East Europe	212 participants n=5 Participants	207 participants n=7 Participants	419 participants n=5 Participants
Region Middle East and Africa	97 participants n=5 Participants	97 participants n=7 Participants	194 participants n=5 Participants
Region Latin America	309 participants n=5 Participants	315 participants n=7 Participants	624 participants n=5 Participants
Region West Europe	904 participants n=5 Participants	912 participants n=7 Participants	1816 participants n=5 Participants
β - Blocker therapy No	543 Participants n=5 Participants	533 Participants n=7 Participants	1076 Participants n=5 Participants
β - Blocker therapy Yes	1370 Participants n=5 Participants	1388 Participants n=7 Participants	2758 Participants n=5 Participants

Outcome measures
Measure	Losartan 50 mg n=1913 Participants	Losartan 150 mg n=1921 Participants
Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure	889 Participants	828 Participants

Outcome measures
Measure	Losartan 50 mg n=1913 Participants	Losartan 150 mg n=1921 Participants
Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization	1085 Participants	1037 Participants

Outcome measures
Measure	Losartan 50 mg n=1913 Participants	Losartan 150 mg n=1921 Participants
Number of Participants That Died (Any Cause)	665 Participants	635 Participants

Outcome measures
Measure	Losartan 50 mg n=1913 Participants	Losartan 150 mg n=1921 Participants
Number of Participants That Were Hospitalized for Heart Failure	503 Participants	450 Participants

Outcome measures
Measure	Losartan 50 mg n=1913 Participants	Losartan 150 mg n=1921 Participants
Number of Participants That Experienced Cardiovascular Hospitalization	826 Participants	762 Participants

General disorders

Blood urine present

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Cardioactive drug level above therapeutic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Cardioactive drug level increased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Ventricular tachycardia

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Congenital, familial and genetic disorders

Hydrocele

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Congenital, familial and genetic disorders

Muscular dystrophy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Acquired haemophilia with anti FVIII, XI, or XIII

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Anaemia

0.99%

19/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

1.2%

24/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Anaemia macrocytic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Anaemia megaloblastic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Anaemia vitamin B12 deficiency

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Bone marrow failure

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Febrile neutropenia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Haemolysis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Haemolytic anaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Haemorrhagic anaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Iron deficiency anaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Lymphadenopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Lymphadenopathy mediastinal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Microcytic anaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Nephrogenic anaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Blood and lymphatic system disorders

Thrombocytopenia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Acute myocardial infarction

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Angina pectoris

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Atrial fibrillation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Atrial flutter

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Atrial tachycardia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Cardiac arrest

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Cardiac failure

0.42%

8/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Cardiogenic shock

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Coronary artery stenosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Cyanosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Intracardiac thrombus

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Myocardial infarction

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Silent myocardial infarction

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Supraventricular tachycardia

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Tachyarrhythmia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Ventricular arrhythmia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Cardiac disorders

Ventricular fibrillation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Ear and labyrinth disorders

Meniere's disease

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Ear and labyrinth disorders

Sudden hearing loss

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Ear and labyrinth disorders

Vertigo

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Ear and labyrinth disorders

Vertigo positional

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Ear and labyrinth disorders

Vestibular disorder

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Endocrine disorders

Adrenal mass

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Endocrine disorders

Goitre

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Endocrine disorders

Hyperthyroidism

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Endocrine disorders

Hypothyroidism

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Cataract

0.68%

13/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.36%

7/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Diabetic retinopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Eye haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Glaucoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Ocular hypertension

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Ophthalmoplegia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Parophthalmia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Retinal detachment

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Retinopathy

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Visual acuity reduced

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Eye disorders

Visual impairment

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Abdominal discomfort

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Abdominal hernia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Abdominal pain

0.47%

9/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Abdominal pain lower

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Abdominal pain upper

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.36%

7/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Abdominal strangulated hernia

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Acute abdomen

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Anal fissure

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Anal fistula

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Anal ulcer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Aphagia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Ascites

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Barrett's oesophagus

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Colitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Colitis ischaemic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Colitis ulcerative

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Colonic polyp

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Constipation

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Dental caries

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Diarrhoea

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Diverticulum

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Diverticulum intestinal

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Dry mouth

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Duodenal perforation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Duodenal stenosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Duodenal ulcer

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Duodenal ulcer haemorrhage

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Duodenal ulcer perforation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Duodenitis haemorrhagic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Dysphagia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Enteritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Enterocolitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Faecaloma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Femoral hernia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Femoral hernia, obstructive

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastric antral vascular ectasia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastric disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastric haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastric ulcer

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.36%

7/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastric ulcer perforation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastritis

0.37%

7/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.62%

12/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastritis erosive

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastritis haemorrhagic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastrointestinal disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastrointestinal haemorrhage

0.68%

13/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.68%

13/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastrointestinal hypomotility

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastrointestinal necrosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastrointestinal ulcer haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Gastrooesophageal reflux disease

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Giant cell epulis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Haematemesis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Haemorrhoidal haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Haemorrhoids

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Ileus

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Ileus paralytic

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Inguinal hernia

0.94%

18/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.57%

11/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Inguinal hernia strangulated

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Intestinal haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Intestinal obstruction

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Intestinal perforation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Intestinal polyp

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Intra-abdominal haematoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Jejunal perforation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Large intestinal haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Large intestine perforation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Mallory-Weiss syndrome

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Melaena

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Nausea

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Oesophageal disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Oesophageal stenosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Oesophageal ulcer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Oesophagitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Pancreatitis

0.37%

7/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Pancreatitis acute

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Pancreatitis chronic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Pancreatitis necrotising

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Peptic ulcer

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Periodontitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Peritoneal effusion

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Peritonitis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Pharyngoesophageal diverticulum

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Polyp colorectal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Rectal haemorrhage

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Rectal polyp

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Rectal prolapse

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Reflux oesophagitis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Retroperitoneal haematoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Retroperitoneal haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Small intestinal haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Small intestinal obstruction

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Subileus

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Toothache

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Umbilical hernia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.63%

12/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.68%

13/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Volvulus

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Gastrointestinal disorders

Vomiting

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood creatinine increased

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood glucose abnormal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood glucose increased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood potassium decreased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood potassium increased

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood pressure increased

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood sodium decreased

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Blood urea increased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

General physical health deterioration

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Coagulation time abnormal

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Coagulation time prolonged

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

International normalised ratio increased

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Prothrombin time prolonged

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Red blood cell count decreased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Urine cytology abnormal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Weight decreased

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Weight increased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

White blood cell count increased

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Asthenia

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Catheter site haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Chest pain

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.47%

9/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Chills

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Drug interaction

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Fatigue

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Generalised oedema

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Granuloma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Hernia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Hernia obstructive

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Hypothermia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Impaired healing

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Implant site haematoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Implant site inflammation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Malaise

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Multi-organ failure

0.47%

9/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Necrosis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Non-cardiac chest pain

0.58%

11/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.52%

10/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Oedema

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Oedema peripheral

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Perforated ulcer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Biliary tract disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Puncture site haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Pyrexia

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Sudden death

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

General disorders

Ulcer haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Acute hepatic failure

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Bile duct obstruction

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Bile duct stenosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Bile duct stone

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Biliary colic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Cholangitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Cholangitis acute

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Cholecystitis

0.63%

12/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.57%

11/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Cholecystitis acute

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Cholelithiasis

0.58%

11/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.78%

15/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Cirrhosis alcoholic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Joint lock

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Gallbladder disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Lumbar spinal stenosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Gallbladder perforation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Hepatic cirrhosis

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Hepatitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Hepatitis acute

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Hepatitis alcoholic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Ischaemic hepatitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Jaundice

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Jaundice cholestatic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Hepatobiliary disorders

Liver disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Immune system disorders

Anaphylactic shock

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Immune system disorders

Behcet's syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Immune system disorders

Contrast media allergy

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Immune system disorders

Hypersensitivity

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Abdominal abscess

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Abdominal infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Abdominal sepsis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Abdominal wall abscess

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Abscess limb

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Anal abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Appendicitis

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Arthritis bacterial

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Arthritis infective

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bacterial pyelonephritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bone tuberculosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Monarthritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Borrelia infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Brain abscess

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Breast abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bronchiectasis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bronchitis

0.94%

18/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.62%

12/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bronchitis bacterial

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bronchitis viral

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Bronchopneumonia

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Carbuncle

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Catheter related infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Cellulitis

0.58%

11/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.47%

9/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Clostridial infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Clostridium difficile colitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Colon gangrene

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Cystitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Device related infection

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Diabetic foot infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Diarrhoea infectious

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Diverticulitis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Empyema

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Erysipelas

0.42%

8/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Escherichia sepsis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Febrile infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Gallbladder empyema

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Gangrene

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Gastroenteritis

0.89%

17/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.99%

19/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Gastroenteritis bacterial

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Gastroenteritis viral

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Gastrointestinal infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Granuloma inguinale

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Groin abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

HIV infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Hepatitis B

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Herpes zoster

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Herpes zoster ophthalmic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Impetigo

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Implant site infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Infected skin ulcer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Infection

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Infective exacerbation of chronic obstructive airways disease

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Klebsiella infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Laryngitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Lobar pneumonia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Localised infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Lower respiratory tract infection

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.42%

8/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Lung infection

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.42%

8/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Necrotising fasciitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Osteomyelitis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Otitis media chronic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Parotitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Penile abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Peritonitis bacterial

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pharyngeal abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pilonidal cyst

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia

4.6%

88/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

3.7%

72/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia bacterial

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia chlamydial

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia legionella

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia necrotising

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia pneumococcal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia staphylococcal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pneumonia streptococcal

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Post procedural infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Postoperative wound infection

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pseudomembranous colitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pulmonary sepsis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pulmonary tuberculosis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pyelonephritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pyelonephritis acute

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pyoderma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Pyothorax

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Respiratory tract infection

0.52%

10/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.62%

12/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Retroperitoneal abscess

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Salmonellosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Sepsis

0.94%

18/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

1.0%

20/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Septic shock

0.37%

7/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.47%

9/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Sinusitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Sinusitis fungal

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Skin infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Staphylococcal infection

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Staphylococcal sepsis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Sweat gland infection

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Tooth abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Tuberculosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Tuberculosis bladder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Tuberculous pleurisy

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Upper respiratory tract infection

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Urinary tract infection

0.94%

18/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.83%

16/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Immune system disorders

Urosepsis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Vaginal abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Vestibular neuronitis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Viral infection

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Wound abscess

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lip and/or oral cavity cancer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Wound infection

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Infections and infestations

Wound infection bacterial

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Accident

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Accidental overdose

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Alcohol poisoning

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Anastomotic haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Ankle fracture

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Cataract operation complication

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Clavicle fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Concussion

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Contusion

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Coronary bypass thrombosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Dislocation of joint prosthesis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Drug dispensing error

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Drug exposure during pregnancy

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Electric shock

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Excoriation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Extradural haematoma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Facial bones fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Fall

0.58%

11/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.62%

12/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Femoral neck fracture

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Femur fracture

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Foot fracture

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Foreign body trauma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Gas poisoning

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Hand fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Head injury

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Hip fracture

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Humerus fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Implantable defibrillator malfunction

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Incisional hernia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Injury

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Joint dislocation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Joint injury

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Ligament injury

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Ligament rupture

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Limb crushing injury

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Lower limb fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Lumbar vertebral fracture

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Medical device complication

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Meniscus lesion

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Multiple injuries

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Muscle injury

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Overdose

0.78%

15/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.83%

16/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Pacemaker complication

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Patella fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Pelvic fracture

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Poisoning

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Post procedural haematoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Post procedural haematuria

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Postoperative renal failure

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipoma of breast

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Postoperative thoracic procedure complication

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Postoperative wound complication

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Procedural complication

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Radius fracture

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Rib fracture

0.42%

8/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Road traffic accident

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Seroma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Skin laceration

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Skull fracture

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Spinal compression fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Spinal fracture

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Sternal fracture

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Subdural haematoma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Subdural haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Suture related complication

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Suture rupture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Tendon rupture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Therapeutic agent toxicity

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Thoracic vertebral fracture

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Tibia fracture

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Traumatic intracranial haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Upper limb fracture

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Urinary retention postoperative

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Wound

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Wound dehiscence

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Injury, poisoning and procedural complications

Wrist fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Cachexia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma of the skin

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Dehydration

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.47%

9/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Diabetes mellitus

0.84%

16/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.78%

15/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Diabetes mellitus inadequate control

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Diabetic foot

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Diabetic ketoacidosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Electrolyte imbalance

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Folate deficiency

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Gout

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypercreatininaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hyperglycaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hyperglycaemic hyperosmolar nonketotic syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hyperkalaemia

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.68%

13/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypoglycaemia

0.68%

13/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.42%

8/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypoglycaemic seizure

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypokalaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypophagia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypoproteinaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Hypovolaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Lipomatosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Metabolic acidosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Metabolic disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Shock hypoglycaemic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Metabolism and nutrition disorders

Type 2 diabetes mellitus

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Arthralgia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Arthritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Articular disc disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Back disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Back pain

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Bone pain

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Bursitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Chondrocalcinosis pyrophosphate

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Chondromalacia

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Costochondritis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Diabetic amyotrophy

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Fibrosis tendinous

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Foot deformity

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Gouty arthritis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Gouty tophus

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Muscle haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Muscle twitching

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Muscular weakness

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Myalgia

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Myositis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Neck mass

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Neck pain

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Osteoarthritis

0.78%

15/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

1.1%

21/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Osteochondrosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Osteolysis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Pain in extremity

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Pathological fracture

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Periarthritis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Polyarthritis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Rhabdomyolysis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Rheumatoid arthritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Rotator cuff syndrome

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Soft tissue haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Spinal column stenosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Spinal disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Musculoskeletal and connective tissue disorders

Tendonitis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Abdominal neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute leukaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute myeloid leukaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adrenal carcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Anal cancer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.47%

9/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign breast neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign pancreatic neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bile duct cancer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer recurrent

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bone cancer metastatic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bone sarcoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain stem glioma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer metastatic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer stage III

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer stage IV

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bronchial carcinoma

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour of the caecum

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic myeloid leukaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon adenoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.47%

9/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer metastatic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer stage II

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Desmoid tumour

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Epiglottic carcinoma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder cancer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.42%

8/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioblastoma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Haemangioblastoma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic neoplasm malignant

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic neoplasm malignant recurrent

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hodgkin's disease recurrent

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Large cell carcinoma of the respiratory tract stage unspecified

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal cancer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Leiomyosarcoma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Leukaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.52%

10/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung squamous cell carcinoma stage II

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung squamous cell carcinoma stage unspecified

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of renal pelvis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant peritoneal neoplasm

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant soft tissue neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Mesothelioma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to bone

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to central nervous system

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to liver

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lymph nodes

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastasis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic bronchial carcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic squamous cell carcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Multiple myeloma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Nasopharyngeal cancer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm malignant

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm prostate

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm skin

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-Hodgkin's lymphoma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer metastatic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal cancer metastatic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal carcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian cancer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian germ cell teratoma benign

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pituitary tumour benign

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Polycythaemia vera

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.73%

14/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.83%

16/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer metastatic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostatic adenoma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Recurrent cancer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Refractory anaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal neoplasm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer stage unspecified

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Superficial spreading melanoma stage III

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thymoma malignant

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tonsil cancer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell cancer of the renal pelvis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell carcinoma

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Urinary tract neoplasm

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine cancer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine leiomyoma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Waldenstrom's macroglobulinaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Altered state of consciousness

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Amyotrophic lateral sclerosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Aphasia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Brain injury

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Brain oedema

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Brain stem syndrome

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Carpal tunnel syndrome

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Cauda equina syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Cerebellar syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Cerebral artery embolism

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Cerebral haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Cerebral infarction

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Cerebrovascular accident

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Convulsion

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Dementia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Dementia Alzheimer's type

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Diabetic hyperosmolar coma

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Dizziness

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.36%

7/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Dizziness postural

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pulmonary fibrosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Dysarthria

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Encephalopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Epilepsy

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Facial palsy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Haemorrhage intracranial

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Headache

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Hepatic encephalopathy

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Hydrocephalus

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Hypercapnic encephalopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Hypoglycaemic coma

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Intercostal neuralgia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Loss of consciousness

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Metabolic encephalopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Myasthenia gravis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Nerve compression

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Orthostatic intolerance

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Paraplegia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Parkinson's disease

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Respiratory acidosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Parkinsonism

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Phantom pain

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Polyneuropathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Presyncope

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Radicular syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Radiculopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Sciatica

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Somnolence

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Spinal cord herniation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Syncope

0.63%

12/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Toxic encephalopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Transient ischaemic attack

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Nervous system disorders

Trigeminal neuralgia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Acute stress disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Alcohol abuse

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Alcoholism

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Anxiety

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Bipolar I disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Respiratory distress

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Confusional state

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Delusion

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Depression

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Disorientation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Hallucination

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Mental disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Personality disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Psychotic disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Reactive psychosis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Schizophrenia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Sleep disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Psychiatric disorders

Suicide attempt

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Acute prerenal failure

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Anuria

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Azotaemia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Calculus bladder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Calculus ureteric

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Diabetic nephropathy

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Glomerulonephritis chronic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Haematuria

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Hydronephrosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Hypertensive nephropathy

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Nephritis allergic

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Nephrolithiasis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Nephrotic syndrome

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Obstructive uropathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Renal artery stenosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Renal failure

1.7%

33/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

2.2%

43/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Renal failure acute

1.1%

21/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

1.1%

21/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Renal failure chronic

0.37%

7/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.31%

6/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Renal impairment

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.47%

9/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Renal mass

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Stress urinary incontinence

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urethral haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urethral meatus stenosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urethral stenosis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urinary incontinence

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urinary retention

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.36%

7/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urinary tract disorder

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Renal and urinary disorders

Urinary tract inflammation

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Adnexa uteri cyst

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.42%

8/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.57%

11/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Breast mass

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Endometrial hyperplasia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Female genital tract fistula

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Genital ulceration

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Hydrometra

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Menorrhagia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Ovarian cyst

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Ovarian cyst torsion

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Perineal fistula

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Prostatic haemorrhage

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Prostatism

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Prostatitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Testicular haemorrhage

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Uterine disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Uterine polyp

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Vaginal haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Reproductive system and breast disorders

Vaginal prolapse

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Acute pulmonary oedema

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Asthma

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.36%

7/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Asthmatic crisis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Atelectasis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Bronchitis chronic

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Bronchospasm

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Bullous lung disease

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

1.4%

26/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

1.5%

28/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Chronic respiratory failure

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Cough

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

0.37%

7/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Emphysema

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Epiglottic cyst

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Haemothorax

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Hiccups

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Hypercapnia

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Idiopathic pulmonary fibrosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Lung infiltration

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Middle lobe syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pneumomediastinum

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pneumonia aspiration

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

0.37%

7/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.26%

5/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Sleep apnoea syndrome

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Status asthmaticus

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Tracheal stenosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Vocal cord polyp

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Respiratory, thoracic and mediastinal disorders

Wegener's granulomatosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Actinic keratosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Angioedema

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Cutaneous vasculitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Dermatitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Dermatitis allergic

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Dermatitis exfoliative

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Diabetic bullosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Diabetic ulcer

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Erythema multiforme

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Erythema nodosum

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Ingrowing nail

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Leukocytoclastic vasculitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Nodular vasculitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Skin exfoliation

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Skin fissures

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Skin lesion

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Skin necrosis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Skin ulcer

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Stevens-Johnson syndrome

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Toxic skin eruption

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Skin and subcutaneous tissue disorders

Urticaria

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Aortic aneurysm

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Arteriosclerosis obliterans

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Bleeding varicose vein

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Deep vein thrombosis

0.16%

3/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Diabetic macroangiopathy

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Extremity necrosis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Haematoma

0.31%

6/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Haemorrhage

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Hot flush

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Hypertension

0.10%

2/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Hypotension

0.21%

4/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.21%

4/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Hypovolaemic shock

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Intermittent claudication

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Ischaemic limb pain

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Orthostatic hypotension

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Peripheral embolism

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Peripheral ischaemia

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Peripheral vascular disorder

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Phlebitis superficial

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Shock

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.16%

3/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Shock haemorrhagic

0.26%

5/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Temporal arteritis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.05%

1/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Thrombophlebitis

0.00%

0/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Varicose ulceration

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.10%

2/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Vascular disorders

Vasculitis

0.05%

1/1913 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

0.00%

0/1921 • All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.

In all adverse experience tables, an individual is counted only once for each system organ class (SOC) (e.g. gastrointestinal disorders) where he/she reported one or more adverse experiences. The Medical Dictionary of Regulatory Activities (MedDRA) Version 12.0 was used in the generation of all tables used in this document.

Trial Outcomes & Findings for Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948) (NCT NCT00090259)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

Adverse Events

Losartan 50 mg

Losartan 150 mg

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Results disclosure agreements