Trial Outcomes & Findings for Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs (NCT NCT00549302)

Last Updated: 2013-04-09

Results Overview

A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

357 participants

Primary outcome timeframe

Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)

Results posted on

2013-04-09

Participant Flow

Participants were previously enrolled in H6D-MC-LVGY (NCT00125918), a placebo-controlled double-blind study.

Participant milestones

Participant milestones
Measure	Tadalafil 20 mg Double Blind Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.	Tadalafil 40 mg Double-Blind Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.	Tadalafil 40 mg Open-Label Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
Double-Blind STARTED	63	294	0
Double-Blind Received at Least One Dose of Study Drug	63	294	0
Double-Blind COMPLETED	52	241	0
Double-Blind NOT COMPLETED	11	53	0
Open-Label STARTED	0	0	286
Open-Label COMPLETED	0	0	217
Open-Label NOT COMPLETED	0	0	69

Reasons for withdrawal

Reasons for withdrawal
Measure	Tadalafil 20 mg Double Blind Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.	Tadalafil 40 mg Double-Blind Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.	Tadalafil 40 mg Open-Label Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
Double-Blind Death	2	9	0
Double-Blind Adverse Event	3	16	0
Double-Blind Withdrawal by Subject	3	8	0
Double-Blind Investigator Decision	1	5	0
Double-Blind Sponsor Decision	0	1	0
Double-Blind Lost to Follow-up	1	2	0
Double-Blind New Drug Pulmonary Atrial Hypertension	1	10	0
Double-Blind New condition or starts new therapy	0	2	0
Open-Label Adverse Event	0	0	11
Open-Label Death	0	0	40
Open-Label Investigator Decision	0	0	5
Open-Label Lost to Follow-up	0	0	2
Open-Label Other	0	0	3
Open-Label New drug pulmonary atrial hypertension	0	0	2
Open-Label Withdrawal by Subject	0	0	6

Baseline Characteristics

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tadalafil 20 Milligrams (mg) Double-Blind n=63 Participants Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.	Tadalafil 40 mg Double-Blind n=294 Participants Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.	Total n=357 Participants Total of all reporting groups
Age Continuous	53.04 years STANDARD_DEVIATION 15.58 • n=5 Participants	53.94 years STANDARD_DEVIATION 15.36 • n=7 Participants	53.78 years STANDARD_DEVIATION 15.38 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	230 Participants n=7 Participants	278 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	64 Participants n=7 Participants	79 Participants n=5 Participants
Region of Enrollment Belgium	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	38 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants	22 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants	34 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Ireland	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants	25 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Japan	5 participants n=5 Participants	17 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	139 participants n=7 Participants	172 participants n=5 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants
Race White	48 participants n=5 Participants	243 participants n=7 Participants	291 participants n=5 Participants
Race Asian	7 participants n=5 Participants	22 participants n=7 Participants	29 participants n=5 Participants
Race Black or African American	5 participants n=5 Participants	23 participants n=7 Participants	28 participants n=5 Participants
Race American Indian or Alaska Native	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race American Indian or Alaska Native/White	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race Black or African American/Native Hawaiian or Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Weight	73.92 kilograms (kg) STANDARD_DEVIATION 18.90 • n=5 Participants	75.26 kilograms (kg) STANDARD_DEVIATION 19.80 • n=7 Participants	75.02 kilograms (kg) STANDARD_DEVIATION 19.63 • n=5 Participants
Ethnicity Hispanic or Latino	4 participants n=5 Participants	36 participants n=7 Participants	40 participants n=5 Participants
Ethnicity Not Hispanic or Latino	59 participants n=5 Participants	258 participants n=7 Participants	317 participants n=5 Participants
Etiology Idiopathic	37 participants n=5 Participants	186 participants n=7 Participants	223 participants n=5 Participants
Etiology Related to Collagen Vascular Disease	16 participants n=5 Participants	62 participants n=7 Participants	78 participants n=5 Participants
Etiology Associated with Atrial Septal Defect	3 participants n=5 Participants	26 participants n=7 Participants	29 participants n=5 Participants
Etiology Related to Anorexigen Use	4 participants n=5 Participants	11 participants n=7 Participants	15 participants n=5 Participants
Etiology Surgical Repair, of at least 1 Year Duration	3 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants
Current Bosentan Use Yes	37 participants n=5 Participants	155 participants n=7 Participants	192 participants n=5 Participants
Current Bosentan Use No	26 participants n=5 Participants	139 participants n=7 Participants	165 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)

Population: Safety Population: all randomized participants who received at least 1 dose of study drug.

A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.

Outcome measures

Outcome measures
Measure	Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label n=357 Participants Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.	Tadalafil 40 mg Double-Blind Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
Number of Participants With Adverse Events (AEs) Serious AEs	184 participants	—
Number of Participants With Adverse Events (AEs) Other Non-Serious AEs	334 participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 28, 40 and 52

Population: All randomized participants who received at least 1 dose of study drug and who completed 6MWD test; Last Observation Carried Forward (LOCF)

6MWD measured the distance a participant was able to walk unassisted in 6 minutes.

Outcome measures

Outcome measures
Measure	Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label n=63 Participants Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.	Tadalafil 40 mg Double-Blind n=284 Participants Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 Distance walked at Baseline (n=63, 287	397.74 meters (m) Standard Deviation 71.74	375.38 meters (m) Standard Deviation 93.41
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 Distance walked at Week 52 (n=51, 235)	415.31 meters (m) Standard Deviation 79.82	394.00 meters (m) Standard Deviation 91.56
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 Distance walked at Week 16 (n=58, 272)	396.37 meters (m) Standard Deviation 77.01	381.47 meters (m) Standard Deviation 96.86
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 Distance walked at Week 28 (n=55, 250)	406.41 meters (m) Standard Deviation 106.76	384.97 meters (m) Standard Deviation 95.03
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 Distance walked at Week 40 (n=51, 241)	411.81 meters (m) Standard Deviation 78.72	386.57 meters (m) Standard Deviation 94.04
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 Endpoint-Week 52 or LOCF (n=60,281)	401.52 meters (m) Standard Deviation 90.29	379.80 meters (m) Standard Deviation 99.12

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 28, 40 and 52

Population: All randomized participants who received at least 1 dose of study drug and who completed the Borg Dyspnea Assessment; LOCF

Borg dyspnea score is a participant rated measure of their greatest degree of shortness of breath during exertion (6-minute walk test). Score ranged from 0 (nothing at all) to 10 (very, very severe \[maximal\]).

Outcome measures

Outcome measures
Measure	Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label n=63 Participants Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.	Tadalafil 40 mg Double-Blind n=294 Participants Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 Score at Week 52 (n=51,235)	3.68 units on a scale Standard Deviation 2.43	3.29 units on a scale Standard Deviation 2.16
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 Endpoint-Week 52 or LOCF (n=60,281)	3.75 units on a scale Standard Deviation 2.34	3.54 units on a scale Standard Deviation 2.36
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 Score at Baseline (n=62, 287)	3.41 units on a scale Standard Deviation 2.38	3.65 units on a scale Standard Deviation 2.43
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 Score at Week 16 (n=58, 271)	3.41 units on a scale Standard Deviation 2.48	3.51 units on a scale Standard Deviation 2.35
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 Score at Week 28 (n=54,249)	3.46 units on a scale Standard Deviation 2.40	3.44 units on a scale Standard Deviation 2.21
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 Score at Week 40 (n=51, 240)	3.21 units on a scale Standard Deviation 2.43	3.38 units on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 28, 40 and 52

Population: Safety Population: all randomized participants who received at least 1 dose of study drug.

World Health Organization Functional Classification Assessment (WHO FC) is a method of classifying disease severity in PAH. The classes are: Class I: pulmonary hypertension (PH) but without resulting limitation of physical activity, Class II: PH resulting in slight limitation of physical activity, Class III: PH resulting in marked limitation of physical activity, Class IV: PH with inability to carry out any physical activity without symptoms. Deterioration of WHO FC is defined as moving to a higher WHO FC within one visit. Results are presented as Kaplan-Meier estimates (% probability) of remaining free from WHO FC deterioration after a given time.

Outcome measures

Outcome measures
Measure	Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label n=63 Participants Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.	Tadalafil 40 mg Double-Blind n=294 Participants Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52 Week 16 (n=57, 262)	95 probability (%) no PAH deterioration Interval 85.0 to 98.0	96 probability (%) no PAH deterioration Interval 93.0 to 98.0
Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52 Week 28 (n=50, 238)	88 probability (%) no PAH deterioration Interval 77.0 to 94.0	90 probability (%) no PAH deterioration Interval 86.0 to 93.0
Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52 Week 40 (n=45, 222)	81 probability (%) no PAH deterioration Interval 68.0 to 89.0	88 probability (%) no PAH deterioration Interval 83.0 to 91.0
Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52 Week 52 (n=33,136)	81 probability (%) no PAH deterioration Interval 68.0 to 89.0	85 probability (%) no PAH deterioration Interval 80.0 to 89.0

Adverse Events

Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label

Serious events: 184 serious events

Other events: 334 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label n=357 participants at risk Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 4/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	7.3% 26/357 • Number of events 28 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 6/357 • Number of events 6 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Skin and subcutaneous tissue disorders Skin ulcer	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Surgical and medical procedures Skin lesion excision	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Aortic stenosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Circulatory collapse	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Haematoma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Haemorrhage	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Hypertension	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Hypertensive crisis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Hypotension	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Paradoxical embolism	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Peripheral vascular disorder	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Thrombosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Blood and lymphatic system disorders Anaemia	2.0% 7/357 • Number of events 11 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Blood and lymphatic system disorders Anaemia macrocytic	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Blood and lymphatic system disorders Neutropenia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Acute coronary syndrome	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Acute myocardial infarction	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Angina pectoris	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Angina unstable	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Aortic valve stenosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Arrhythmia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Arrhythmia supraventricular	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Atrial fibrillation	2.0% 7/357 • Number of events 11 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Atrial flutter	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Atrial tachycardia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Atrioventricular block complete	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardiac arrest	1.4% 5/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardiac failure	2.5% 9/357 • Number of events 10 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardiac failure congestive	2.8% 10/357 • Number of events 16 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardiac flutter	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardio-respiratory arrest	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardio-respiratory distress	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardiogenic shock	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cardiopulmonary failure	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cor pulmonale	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Coronary artery disease	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Cyanosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Hypertensive heart disease	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Mitral valve incompetence	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Myocardial infarction	1.1% 4/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Palpitations	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Pericardial haemorrhage	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Right ventricular dysfunction	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Right ventricular failure	7.8% 28/357 • Number of events 36 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Sick sinus syndrome	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Sinus arrhythmia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Supraventricular tachycardia	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Ventricular tachycardia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Ear and labyrinth disorders Vertigo	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Endocrine disorders Hypothyroidism	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Eye disorders Cataract	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Eye disorders Retinal detachment	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Eye disorders Visual disturbance	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Abdominal pain	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Colitis ischaemic	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Colonic polyp	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Dental caries	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Diarrhoea	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Gastric volvulus	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.2% 8/357 • Number of events 10 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Gastrointestinal ulcer	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Gingival hypertrophy	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Hiatus hernia	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Intestinal obstruction	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Intestinal polyp	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Oesophageal achalasia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Oesophageal stenosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Pancreatitis	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Rectal haemorrhage	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Umbilical hernia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Chest discomfort	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Chest pain	2.0% 7/357 • Number of events 9 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Chills	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Cyst	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Death	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Device malfunction	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Fatigue	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Injection site haemorrhage	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Medical device complication	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Non-cardiac chest pain	1.1% 4/357 • Number of events 4 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Oedema peripheral	1.4% 5/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Pyrexia	0.84% 3/357 • Number of events 4 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Sensation of pressure	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Sudden cardiac death	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Sudden death	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Hepatobiliary disorders Cholecystitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Hepatobiliary disorders Cholecystitis acute	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Hepatobiliary disorders Cholelithiasis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Hepatobiliary disorders Hepatitis toxic	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Bacteraemia	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Bronchiolitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Bronchitis	1.7% 6/357 • Number of events 6 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Bronchitis bacterial	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Campylobacter infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Campylobacter intestinal infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Cellulitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Clostridial infection	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Clostridium difficile colitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Cystitis	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Device related infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Diverticulitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Erysipelas	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Gastroenteritis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Gastroenteritis salmonella	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Gastroenteritis viral	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Herpes zoster ophthalmic	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Influenza	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Lobar pneumonia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Lower respiratory tract infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Lung infection	0.84% 3/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Mycobacterial infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Nasopharyngitis	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Parotitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Pneumonia	4.5% 16/357 • Number of events 19 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Pneumonia staphylococcal	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Pulmonary tuberculosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Respiratory tract infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Sepsis	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Septic shock	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Sinusitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Staphylococcal bacteraemia	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Staphylococcal skin infection	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Tracheobronchitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Upper respiratory tract infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Urinary tract infection	0.56% 2/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Viral infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Viral upper respiratory tract infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Wound infection	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Accidental overdose	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Fall	1.1% 4/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Femur fracture	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Fibula fracture	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Fractured sacrum	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Hip fracture	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Humerus fracture	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Incisional hernia	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Post procedural discharge	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Post procedural haematoma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Postoperative wound complication	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Pubic rami fracture	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Rib fracture	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Road traffic accident	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Subdural haematoma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Tibia fracture	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Injury, poisoning and procedural complications Toxicity to various agents	0.56% 2/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Investigations Blood pressure increased	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Investigations C-reactive protein increased	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Investigations Cardiac output decreased	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Investigations International normalised ratio increased	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Dehydration	1.7% 6/357 • Number of events 6 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Diabetes mellitus	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Fluid overload	1.1% 4/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Fluid retention	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Hyperglycaemia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Hypokalaemia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Hypomagnesaemia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Hyponatraemia	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Arthralgia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Arthritis	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Back pain	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Bunion	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Bursitis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Exostosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Osteolysis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Pain in extremity	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Scleroderma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.28% 1/357 • Number of events 3 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Systemic sclerosis	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer stage iv	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyosarcoma	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Ataxia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Cerebrovascular accident	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Cervical myelopathy	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Complicated migraine	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Dementia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Depressed level of consciousness	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Dizziness	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Dystonia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Haemorrhage intracranial	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Headache	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Hypoaesthesia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Presyncope	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Syncope	2.8% 10/357 • Number of events 10 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Transient ischaemic attack	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Pregnancy, puerperium and perinatal conditions Premature labour	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Anxiety disorder	0.28% 1/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Bipolar disorder	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Confusional state	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Delirium	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Depression	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Emotional disorder	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Mental status changes	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Suicide attempt	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Withdrawal syndrome	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Renal and urinary disorders Proteinuria	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Renal and urinary disorders Renal failure	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Renal and urinary disorders Renal failure acute	1.4% 5/357 • Number of events 7 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Renal and urinary disorders Renal failure chronic	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Renal and urinary disorders Renal impairment	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Reproductive system and breast disorders Menorrhagia	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Reproductive system and breast disorders Ovarian cyst	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Reproductive system and breast disorders Ovarian cyst ruptured	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Aspiration	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Asthma	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.84% 3/357 • Number of events 4 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 5/357 • Number of events 6 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.28% 1/357 • Number of events 1 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.84% 3/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.1% 4/357 • Number of events 5 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.56% 2/357 • Number of events 2 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.

Other adverse events

Other adverse events
Measure	Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label n=357 participants at risk Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
Blood and lymphatic system disorders Anaemia	11.8% 42/357 • Number of events 51 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Cardiac disorders Palpitations	14.6% 52/357 • Number of events 61 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Eye disorders Vision blurred	6.2% 22/357 • Number of events 23 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Diarrhoea	21.6% 77/357 • Number of events 107 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Dyspepsia	9.8% 35/357 • Number of events 39 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 19/357 • Number of events 19 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Nausea	12.3% 44/357 • Number of events 56 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Gastrointestinal disorders Vomiting	5.0% 18/357 • Number of events 22 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Asthenia	5.0% 18/357 • Number of events 18 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Chest pain	10.6% 38/357 • Number of events 45 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Fatigue	13.7% 49/357 • Number of events 56 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
General disorders Oedema peripheral	17.6% 63/357 • Number of events 82 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Bronchitis	9.5% 34/357 • Number of events 44 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Influenza	7.3% 26/357 • Number of events 31 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Nasopharyngitis	17.9% 64/357 • Number of events 110 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Respiratory tract infection	5.3% 19/357 • Number of events 30 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Sinusitis	7.6% 27/357 • Number of events 42 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Upper respiratory tract infection	17.6% 63/357 • Number of events 105 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Infections and infestations Urinary tract infection	10.4% 37/357 • Number of events 59 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Metabolism and nutrition disorders Hypokalaemia	5.6% 20/357 • Number of events 25 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Arthralgia	11.2% 40/357 • Number of events 43 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Back pain	17.9% 64/357 • Number of events 76 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Muscle spasms	8.1% 29/357 • Number of events 31 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 19/357 • Number of events 19 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Myalgia	7.8% 28/357 • Number of events 30 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Musculoskeletal and connective tissue disorders Pain in extremity	12.3% 44/357 • Number of events 51 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Dizziness	17.1% 61/357 • Number of events 73 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Headache	30.0% 107/357 • Number of events 130 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Nervous system disorders Syncope	5.6% 20/357 • Number of events 25 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Anxiety	6.4% 23/357 • Number of events 24 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Depression	6.2% 22/357 • Number of events 25 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Psychiatric disorders Insomnia	10.1% 36/357 • Number of events 37 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Cough	15.1% 54/357 • Number of events 61 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.4% 55/357 • Number of events 69 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.9% 39/357 • Number of events 44 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.6% 27/357 • Number of events 31 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	9.2% 33/357 • Number of events 41 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Skin and subcutaneous tissue disorders Rash	8.1% 29/357 • Number of events 32 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Vascular disorders Flushing	7.8% 28/357 • Number of events 30 All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60