Trial Outcomes & Findings for Secondary Prevention of Venous Thrombo Embolism (VTE). (NCT NCT00329238)

NCT ID: NCT00329238

Last Updated: 2014-05-19

Results Overview

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2867 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2014-05-19

Participant Flow

Participant milestones

Measure	Dabigatran 150 mg twice daily, total daily dose 300 mg	Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Study STARTED	1430	1426
Overall Study COMPLETED	1154	1145
Overall Study NOT COMPLETED	276	281

Reasons for withdrawal

Measure	Dabigatran 150 mg twice daily, total daily dose 300 mg	Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0
Overall Study Adverse Event	147	129
Overall Study Protocol Violation	23	34
Overall Study Lost to Follow-up	2	6
Overall Study Withdrawal by Subject	64	58
Overall Study Other reason (not specified)	40	54

Baseline Characteristics

Secondary Prevention of Venous Thrombo Embolism (VTE).

Baseline characteristics by cohort

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0	Total n=2856 Participants Total of all reporting groups
Race/Ethnicity, Customized Not Hispanic/Latino	1325 Participants n=5 Participants	1317 Participants n=7 Participants	2642 Participants n=5 Participants
Age, Continuous	55.38 years STANDARD_DEVIATION 14.99 • n=5 Participants	53.90 years STANDARD_DEVIATION 15.34 • n=7 Participants	54.64 years STANDARD_DEVIATION 15.18 • n=5 Participants
Age, Customized >=18 to <40 years	237 participants n=5 Participants	269 participants n=7 Participants	506 participants n=5 Participants
Age, Customized >=40 to <50 years	250 participants n=5 Participants	291 participants n=7 Participants	541 participants n=5 Participants
Age, Customized >=50 to <65 years	500 participants n=5 Participants	459 participants n=7 Participants	959 participants n=5 Participants
Age, Customized >=65 to <75 years	303 participants n=5 Participants	288 participants n=7 Participants	591 participants n=5 Participants
Age, Customized >= 75 years	140 participants n=5 Participants	119 participants n=7 Participants	259 participants n=5 Participants
Sex: Female, Male Female	559 Participants n=5 Participants	555 Participants n=7 Participants	1114 Participants n=5 Participants
Sex: Female, Male Male	871 Participants n=5 Participants	871 Participants n=7 Participants	1742 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	105 Participants n=5 Participants	109 Participants n=7 Participants	214 Participants n=5 Participants
Race/Ethnicity, Customized White	1288 Participants n=5 Participants	1284 Participants n=7 Participants	2572 Participants n=5 Participants
Race/Ethnicity, Customized Black	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Asian	113 Participants n=5 Participants	114 Participants n=7 Participants	227 Participants n=5 Participants
Height	171.55 cm STANDARD_DEVIATION 9.73 • n=5 Participants	171.95 cm STANDARD_DEVIATION 10.08 • n=7 Participants	171.75 cm STANDARD_DEVIATION 9.90 • n=5 Participants
Weight	86.09 kg STANDARD_DEVIATION 19.26 • n=5 Participants	85.95 kg STANDARD_DEVIATION 18.87 • n=7 Participants	86.02 kg STANDARD_DEVIATION 19.06 • n=5 Participants
Weight category < 50 kg	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Weight category >= 50 to < 100 kg	1120 Participants n=5 Participants	1117 Participants n=7 Participants	2237 Participants n=5 Participants
Weight category >= 100 kg	299 Participants n=5 Participants	300 Participants n=7 Participants	599 Participants n=5 Participants
Weight category Missing	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Body Mass Index (BMI)	29.15 kg/square meter STANDARD_DEVIATION 5.65 • n=5 Participants	29.01 kg/square meter STANDARD_DEVIATION 5.75 • n=7 Participants	29.08 kg/square meter STANDARD_DEVIATION 5.70 • n=5 Participants
Body Mass Index (BMI) category <25 kg/square meter	315 Participants n=5 Participants	334 Participants n=7 Participants	649 Participants n=5 Participants
Body Mass Index (BMI) category >=25 to <30 kg/square meter	571 Participants n=5 Participants	584 Participants n=7 Participants	1155 Participants n=5 Participants
Body Mass Index (BMI) category >=30 to <35 kg/square meter	356 Participants n=5 Participants	330 Participants n=7 Participants	686 Participants n=5 Participants
Body Mass Index (BMI) category >= 35 kg/square meter	186 Participants n=5 Participants	174 Participants n=7 Participants	360 Participants n=5 Participants
Body Mass Index (BMI) category Missing	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Smoking history Non-smoker	814 Participants n=5 Participants	829 Participants n=7 Participants	1643 Participants n=5 Participants
Smoking history Ex-smoker	393 Participants n=5 Participants	366 Participants n=7 Participants	759 Participants n=5 Participants
Smoking history Current smoker	223 Participants n=5 Participants	231 Participants n=7 Participants	454 Participants n=5 Participants
Serum creatinine clearance	104.2 mL/min STANDARD_DEVIATION 38.6 • n=5 Participants	106.6 mL/min STANDARD_DEVIATION 37.9 • n=7 Participants	105.4 mL/min STANDARD_DEVIATION 38.3 • n=5 Participants
Serum creatinine clearance category >=0 to <30 mL/min	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Serum creatinine clearance category >=30 to <50 mL/min	59 Participants n=5 Participants	45 Participants n=7 Participants	104 Participants n=5 Participants
Serum creatinine clearance category >=50 to <80 mL/min	328 Participants n=5 Participants	289 Participants n=7 Participants	617 Participants n=5 Participants
Serum creatinine clearance category >= 80 mL/min	1031 Participants n=5 Participants	1072 Participants n=7 Participants	2103 Participants n=5 Participants
Serum creatinine clearance category Missing	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: FAS

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Composite of Recurrent VTE or VTE Death at 36 Months Number of participants with event	26 Participants	18 Participants
Composite of Recurrent VTE or VTE Death at 36 Months Number of participants with no event	1404 Participants	1408 Participants

PRIMARY outcome

Timeframe: 18 months

Population: FAS

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Composite of Recurrent VTE or VTE Death at 18 Months Number of participants with event	22 Participants	17 Participants
Composite of Recurrent VTE or VTE Death at 18 Months Number of participants with no event	1408 Participants	1409 Participants

SECONDARY outcome

Timeframe: 36 months

Population: FAS

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Composite of Recurrent VTE or All Cause Death at 36 Months Number of participants with event	42 Participants	36 Participants
Composite of Recurrent VTE or All Cause Death at 36 Months Number of participants with no event	1388 Participants	1390 Participants

SECONDARY outcome

Timeframe: 18 months

Population: FAS

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Composite of Recurrent VTE or All Cause Death at 18 Months Number of participants with event	36 Participants	32 Participants
Composite of Recurrent VTE or All Cause Death at 18 Months Number of participants with no event	1394 Participants	1394 Participants

SECONDARY outcome

Timeframe: 36 months

Population: FAS

Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Deep Vein Thrombosis (DVT) at 36 Months Number of participants with event	17 Participants	13 Participants
Deep Vein Thrombosis (DVT) at 36 Months Number of participants with no event	1413 Participants	1413 Participants

SECONDARY outcome

Timeframe: 18 months

Population: FAS

Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
DVT at 18 Months Number of participants with event	15 Participants	12 Participants
DVT at 18 Months Number of participants with no event	1415 Participants	1414 Participants

SECONDARY outcome

Timeframe: 36 months

Population: FAS

Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Symptomatic Pulmonary Embolism (PE) at 36 Months Number of participants with event	10 Participants	5 Participants
Symptomatic Pulmonary Embolism (PE) at 36 Months Number of participants with no event	1420 Participants	1421 Participants

SECONDARY outcome

Timeframe: 18 months

Population: FAS

Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Symptomatic Pulmonary Embolism (PE) at 18 Months Number of participants with event	8 Participants	5 Participants
Symptomatic Pulmonary Embolism (PE) at 18 Months Number of participants with no event	1422 Participants	1421 Participants

SECONDARY outcome

Timeframe: 36 months

Population: FAS

Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Deaths Related to VTE at 36 Months Number of participants with event	1 Participants	1 Participants
Deaths Related to VTE at 36 Months Number of participants with no event	1429 Participants	1425 Participants

SECONDARY outcome

Timeframe: 18 months

Population: FAS

Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Deaths Related to VTE at 18 Months Number of participants with event	1 Participants	1 Participants
Deaths Related to VTE at 18 Months Number of participants with no event	1429 Participants	1425 Participants

SECONDARY outcome

Timeframe: 36 months

Population: FAS

Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Deaths of All Causes at 36 Months Number of participants with event	17 Participants	19 Participants
Deaths of All Causes at 36 Months Number of participants with no event	1413 Participants	1407 Participants

SECONDARY outcome

Timeframe: 18 months

Population: FAS

Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Deaths of All Causes at 18 Months Number of participants with no event	1415 Participants	1410 Participants
Deaths of All Causes at 18 Months Number of participants with event	15 Participants	16 Participants

SECONDARY outcome

Timeframe: first intake of study drug until 6 days following last intake of study drug

Population: FAS as treated

MBE (major bleeding event) if it fulfilled at least one of the following criteria

• Fatal bleeding
• Symptomatic bleeding in a critical area or organ.
• Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.

Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs

CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria

• Spontaneous skin haematoma ≥25 cm2
• Spontaneous nose bleed >5 min duration
• Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
• Spontaneous rectal bleeding
• Gingival bleeding >5 min
• Bleeding leading to hospitalisation or requiring surgical treatment
• Bleeding leading to a transfusion of <2 units of whole blood or red cells
• Any other bleeding event considered clinically relevant by the investigator

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Number of Participants With Bleeding Events patients with MBE	13 participants	25 participants
Number of Participants With Bleeding Events patients with MBE and /or CRBE	80 participants	145 participants
Number of Participants With Bleeding Events patients with any bleeding event	277 participants	373 participants

SECONDARY outcome

Timeframe: 18 months + 30 days follow up

Population: FAS as treated

Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).

Outcome measures

Measure	Dabigatran n=1411 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1402 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Laboratory Analysis ALT increase	26 participants	30 participants
Laboratory Analysis AST increase	23 participants	23 participants
Laboratory Analysis Alkaline phosphatase	9 participants	14 participants
Laboratory Analysis Total bilirubin	9 participants	8 participants

SECONDARY outcome

Timeframe: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

Population: FAS as treated

All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.

Outcome measures

Measure	Dabigatran n=1430 Participants 150 mg twice daily, total daily dose 300 mg	Warfarin n=1415 Participants Target International Normalized Ratio (INR) of 2.0 to 3.0
Number of Participants With Definite Acute Coronary Syndrome (ACS) During intake of study drug, N=1430 , N=1415	12 participants	2 participants
Number of Participants With Definite Acute Coronary Syndrome (ACS) After stopping study drug, N=1426, N=1400	1 participants	5 participants

Adverse Events

Dabigatran

Serious events: 227 serious events

Other events: 409 other events

Deaths: 0 deaths

Warfarin

Serious events: 224 serious events

Other events: 415 other events

Deaths: 0 deaths

Post Dabigatran

Serious events: 33 serious events

Other events: 34 other events

Deaths: 0 deaths

Post Warfarin

Serious events: 41 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dabigatran n=1430 participants at risk 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 participants at risk Target International Normalized Ratio (INR) of 2.0 to 3.0	Post Dabigatran n=1395 participants at risk	Post Warfarin n=1384 participants at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penis carcinoma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.35% 5/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.49% 7/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Omentum neoplasm	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer recurrent	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Blood and lymphatic system disorders Anaemia	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Blood and lymphatic system disorders Anaemia megaloblastic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Blood and lymphatic system disorders Iron deficiency anaemia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Blood and lymphatic system disorders Neutropenia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Blood and lymphatic system disorders Splenic infarction	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Acute coronary syndrome	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Acute left ventricular failure	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Acute myocardial infarction	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Angina pectoris	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Angina unstable	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Atrial fibrillation	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Atrial flutter	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Atrial tachycardia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiac arrest	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiac asthma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiac failure	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiac failure chronic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiac failure congestive	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardio-respiratory arrest	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiogenic shock	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiomegaly	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiomyopathy	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cardiopulmonary failure	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Congestive cardiomyopathy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Cor pulmonale	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Coronary artery disease	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Coronary artery occlusion	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Coronary artery stenosis	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Left ventricular failure	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Myocardial infarction	0.42% 6/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Myocardial ischaemia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Palpitations	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Supraventricular tachycardia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Tachycardia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Cardiac disorders Ventricular tachycardia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Congenital, familial and genetic disorders Metabolic myopathy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Congenital, familial and genetic disorders Vitello-intestinal duct remnant	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Ear and labyrinth disorders Hypoacusis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Ear and labyrinth disorders Vertigo	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Endocrine disorders Goitre	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Cataract	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Diabetic retinopathy	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Diplopia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Retinal detachment	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Retinal vascular thrombosis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Trichiasis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Eye disorders Vitreous haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Abdominal hernia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Abdominal hernia obstructive	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Abdominal pain	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.56% 8/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Abdominal pain lower	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Abdominal pain upper	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Acute abdomen	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Colonic polyp	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Constipation	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Diarrhoea	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Diverticular perforation	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Duodenal ulcer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Duodenitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Faecal incontinence	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Faecal vomiting	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastric polyps	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastric ulcer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastritis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastritis erosive	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastrointestinal haemorrhage	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastrointestinal hypomotility	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastrointestinal pain	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gastrooesophageal reflux disease	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Gingival bleeding	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Hernial eventration	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Hiatus hernia	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Ileus	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Inguinal hernia	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Intestinal polyp	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Intestinal strangulation	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Large intestine perforation	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Melaena	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Mouth ulceration	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Nausea	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Pancreatitis acute	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Pancreatitis chronic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Pancreatitis relapsing	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Peritoneal haematoma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Peritonitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Rectal haemorrhage	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Reflux oesophagitis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Subileus	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Umbilical hernia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Umbilical hernia, obstructive	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Gastrointestinal disorders Vomiting	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Adverse drug reaction	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Asthenia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Chest discomfort	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Chest pain	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.63% 9/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Death	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Device breakage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Device occlusion	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Diapedesis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Facial pain	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Fatigue	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders General physical health deterioration	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Hernia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Hypothermia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Inflammation	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Mass	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Non-cardiac chest pain	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Oedema	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Oedema peripheral	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Pain	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Pyrexia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Sudden death	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Bile duct stone	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Cholangitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Cholecystitis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Cholecystitis acute	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Cholecystitis chronic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Cholelithiasis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Chronic hepatitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Hepatic steatosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Hepatobiliary disorders Jaundice cholestatic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Immune system disorders Hypersensitivity	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Abdominal abscess	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Appendicitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Bacteraemia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Bronchiolitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Bronchitis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Bronchopneumonia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Cellulitis	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.35% 5/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Diverticulitis	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Endometritis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Erysipelas	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Gangrene	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Gingival abscess	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Gnathostomiasis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Infected skin ulcer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Infection	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Liver abscess	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Lobar pneumonia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Lower respiratory tract infection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Lung infection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Lymphangitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Meningococcal sepsis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Necrotising fasciitis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Oral herpes	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Otitis externa	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Pneumonia	0.42% 6/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.35% 5/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Pneumonia staphylococcal	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Pneumonia viral	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Postoperative wound infection	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Pulpitis dental	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Purulence	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Purulent discharge	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Pyelonephritis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Rectal abscess	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Respiratory tract infection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Scrotal abscess	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Sepsis	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.22% 3/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Septic shock	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Sinusitis	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Tooth infection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Urinary tract infection	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Urosepsis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Viral infection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Wound infection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Accidental drug intake by child	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Chest injury	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Concussion	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Contusion	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Drug exposure during pregnancy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Eye injury	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Face injury	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Fall	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Femoral neck fracture	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Femur fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Foot fracture	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Hand fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Hip fracture	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Incisional hernia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Injury	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Joint injury	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Lower limb fracture	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Overdose	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Periorbital haematoma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Perirenal haematoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Radius fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Renal haematoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Road traffic accident	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Skin laceration	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Splenic rupture	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Stab wound	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Tibia fracture	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Vascular graft occlusion	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Wound	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Injury, poisoning and procedural complications Wound secretion	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Alanine aminotransferase increased	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Arteriogram coronary normal	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Aspartate aminotransferase increased	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Blood creatinine increased	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Body temperature increased	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Coagulation time prolonged	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Gamma-glutamyltransferase increased	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Hepatic enzyme increased	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations International normalised ratio increased	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Investigations Weight decreased	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Metabolism and nutrition disorders Dehydration	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Metabolism and nutrition disorders Diabetes mellitus	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Metabolism and nutrition disorders Hyperglycaemia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Metabolism and nutrition disorders Hyperlipidaemia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Metabolism and nutrition disorders Hypoproteinaemia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Amyotrophy	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Arthralgia	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Arthritis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Back pain	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Bone pain	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Costochondritis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Foot deformity	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Muscular weakness	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Myalgia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Neck pain	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Osteoarthritis	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Pain in extremity	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Pain in jaw	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Periostitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Sacroiliitis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Spinal disorder	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine carcinoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bladder	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to retroperitoneum	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Morton's neuroma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Brain stem stroke	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Carotid artery dissection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Carpal tunnel syndrome	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Cerebral haematoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Cerebral haemorrhage	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Cerebral infarction	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Cerebral thrombosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Cerebrovascular accident	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Cognitive disorder	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Coma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Convulsion	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Diabetic encephalopathy	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Diabetic neuropathy	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Dizziness	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Epilepsy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Facial neuralgia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Guillain-Barre syndrome	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Headache	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Hemiparesis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Intercostal neuralgia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Ischaemic stroke	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Lacunar infarction	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Loss of consciousness	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Motor dysfunction	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Multiple sclerosis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Parkinson's disease	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Presyncope	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Sciatica	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.22% 3/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Sensory disturbance	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Sensory loss	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Syncope	0.28% 4/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Transient ischaemic attack	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders VIIth nerve paralysis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Vascular encephalopathy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Pregnancy, puerperium and perinatal conditions Eclampsia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Psychiatric disorders Bipolar disorder	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Psychiatric disorders Completed suicide	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Psychiatric disorders Depression	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Psychiatric disorders Mental disorder	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Psychiatric disorders Suicide attempt	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Calculus ureteric	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Dysuria	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Haematuria	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.42% 6/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Hydronephrosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Nephrolithiasis	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Nephropathy	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Nephrotic syndrome	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Pollakiuria	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Renal artery stenosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Renal colic	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Renal failure	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Renal failure acute	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Renal haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Renal infarct	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Urinary bladder polyp	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Urinary incontinence	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Renal and urinary disorders Urinary retention	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Benign prostatic hyperplasia	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.28% 4/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Endometriosis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Epididymal enlargement	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Menometrorrhagia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Menorrhagia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Metrorrhagia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Prostatitis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Uterine polyp	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Vaginal discharge	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Alveolitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Asthma	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Cough	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.35% 5/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Lung disorder	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.63% 9/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.22% 3/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.21% 3/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Pruritus	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Rash	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Skin ulcer	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Skin and subcutaneous tissue disorders Vascular purpura	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Abortion induced	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Colostomy closure	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Femoral hernia repair	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Finger amputation	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Hip arthroplasty	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Incisional hernia repair	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Joint arthroplasty	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Knee arthroplasty	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Rotator cuff repair	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Surgical and medical procedures Tooth extraction	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Aneurysm ruptured	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Aortic aneurysm	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Aortic dissection	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Arterial insufficiency	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Arterial thrombosis limb	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Arteriosclerosis	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Circulatory collapse	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Deep vein thrombosis	0.70% 10/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.42% 6/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Haematoma	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.21% 3/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Haemorrhage	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Hypertension	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Hypotension	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Hypovolaemic shock	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Lymphoedema	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Peripheral artery aneurysm	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Peripheral embolism	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Peripheral ischaemia	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Phlebitis	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Post thrombotic syndrome	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Shock	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Thrombophlebitis superficial	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Thrombosis	0.14% 2/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Varicose ulceration	0.00% 0/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.07% 1/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Varicose vein	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Vascular disorders Venous insufficiency	0.07% 1/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.00% 0/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment

Other adverse events

Measure	Dabigatran n=1430 participants at risk 150 mg twice daily, total daily dose 300 mg	Warfarin n=1426 participants at risk Target International Normalized Ratio (INR) of 2.0 to 3.0	Post Dabigatran n=1395 participants at risk	Post Warfarin n=1384 participants at risk
Gastrointestinal disorders Diarrhoea	5.1% 73/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	3.6% 51/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.29% 4/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.22% 3/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
General disorders Oedema peripheral	5.3% 76/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	4.8% 68/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.57% 8/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.22% 3/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Influenza	5.2% 75/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	4.7% 67/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.14% 2/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.79% 11/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Infections and infestations Nasopharyngitis	7.8% 112/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	8.9% 127/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.36% 5/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.58% 8/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Musculoskeletal and connective tissue disorders Pain in extremity	7.6% 109/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	7.7% 110/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.65% 9/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.43% 6/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Nervous system disorders Headache	5.9% 84/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	7.0% 100/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.29% 4/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.58% 8/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	3.2% 46/1430 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	6.5% 92/1426 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.50% 7/1395 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment	0.22% 3/1384 • 18-month treatment period 30-day follow-up period subsequent to the completion of treatment

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER