Trial Outcomes & Findings for A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease (NCT NCT01732822)

NCT ID: NCT01732822

Last Updated: 2017-10-30

Results Overview

Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 13885 participants
• Primary outcome timeframe: From randomization to PACD, an average of 2.5 years
• Results posted on: 2017-10-30

Participant Flow

This study was conducted at 821 centres randomising patients across 28 countries. The first patient was enrolled on 04 December 2012. The last visit of the last patient took place on 26 September 2016. In total, 16237 patients were screened.

Screened patients randomised to study drug: 85.5%; n=13885 Patients who were not randomised: 14.5%; n=2352 Patients with inclusion criteria for symptomatic lower extremity PAD failed: n=489 Patients with poor metabolizer status for CYP2C19: n=616 Patients with other reason: n=1374

Participant milestones

Measure	Ticagrelor 90 mg bd	Clopidogrel 75 mg od
Overall Study STARTED	6930	6955
Overall Study COMPLETED	6807	6842
Overall Study NOT COMPLETED	123	113

Reasons for withdrawal

Measure	Ticagrelor 90 mg bd	Clopidogrel 75 mg od
Overall Study Withdrawal by Subject	123	113

Baseline Characteristics

A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease

Baseline characteristics by cohort

Measure	Ticagrelor 90mg bd n=6930 Participants	Clopidogrel 75mg od n=6955 Participants	Total n=13885 Participants Total of all reporting groups
Age, Continuous Age	66.6 Years STANDARD_DEVIATION 8.4 • n=5 Participants	66.5 Years STANDARD_DEVIATION 8.5 • n=7 Participants	66.6 Years STANDARD_DEVIATION 8.4 • n=5 Participants
Age, Customized <65 years	2900 Participants n=5 Participants	2985 Participants n=7 Participants	5885 Participants n=5 Participants
Age, Customized Between 65 and 75 years	2925 Participants n=5 Participants	2850 Participants n=7 Participants	5775 Participants n=5 Participants
Age, Customized >75 years	1105 Participants n=5 Participants	1120 Participants n=7 Participants	2225 Participants n=5 Participants
Sex: Female, Male Female	1908 Participants n=5 Participants	1980 Participants n=7 Participants	3888 Participants n=5 Participants
Sex: Female, Male Male	5022 Participants n=5 Participants	4975 Participants n=7 Participants	9997 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Or Latino	1046 Participants n=5 Participants	1067 Participants n=7 Participants	2113 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic Or Latino	5884 Participants n=5 Participants	5888 Participants n=7 Participants	11772 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Race/Ethnicity, Customized Asian	824 Participants n=5 Participants	810 Participants n=7 Participants	1634 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	280 Participants n=5 Participants	289 Participants n=7 Participants	569 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	110 Participants n=5 Participants	132 Participants n=7 Participants	242 Participants n=5 Participants
Race/Ethnicity, Customized White	5651 Participants n=5 Participants	5659 Participants n=7 Participants	11310 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients.

Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke	751 Participants	740 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Composite of CV Death, MI, Ischemic Stroke, and ALI	839 Participant	833 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
CV Death	363 Participant	343 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
MI	349 Participant	334 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
All-cause Mortality	628 Participant	635 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)	766 Participant	759 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
ALI	117 Participant	115 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Lower Extremity Revascularization	846 Participant	892 Participant	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])	1211 Participant	1250 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)	789 Participant	786 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)	983 Participant	992 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)	1119 Participant	1140 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)	1183 Participant	1199 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Non-CV Death	250 Participant	272 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.

Stage I - Asymptomatic Stage IIa - Intermittent claudication after more than 200 meters of pain free walking Stage IIb - Intermittent claudication after less than 200 meters of walking Stage III - Rest pain Stage IV - Ischemic ulcers or gangrene

Outcome measures

Measure	Ticagrelor 90 mg bd n=1309 Participants	Clopidogrel 75 mg od n=3674 Participants	Ticagrelor - Stage IIb n=1620 Participants Baseline Fontaine stage IIb	Ticagrelor - Stage III n=186 Participants Baseline Fontaine stage III	Ticagrelor - Stage IV n=140 Participants Baseline Fontaine stage IV	Clopidogrel - Stage I n=1292 Participants Baseline Fontaine stage I	Clopidogrel - Stage IIa n=3736 Participants Baseline Fontaine stage IIa	Clopidogrel - Stage IIb n=1608 Participants Baseline Fontaine stage IIb	Clopidogrel - Stage III n=192 Participants Baseline Fontaine stage III	Clopidogrel - Stage IV n=125 Participants Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Changes in Fontaine Stage Stage IIa - End of treatment	227 Participant	1948 Participant	560 Participant	41 Participant	28 Participant	230 Participant	1956 Participant	557 Participant	33 Participant	21 Participant	—	—
Changes in Fontaine Stage Stage I - End of treatment	775 Participant	683 Participant	171 Participant	15 Participant	26 Participant	743 Participant	723 Participant	198 Participant	33 Participant	19 Participant	—	—
Changes in Fontaine Stage Stage IIb - End of treatment	45 Participant	269 Participant	469 Participant	39 Participant	19 Participant	56 Participant	311 Participant	450 Participant	38 Participant	15 Participant	—	—
Changes in Fontaine Stage Stage III - End of treatment	7 Participant	24 Participant	12 Participant	31 Participant	7 Participant	9 Participant	15 Participant	23 Participant	23 Participant	12 Participant	—	—
Changes in Fontaine Stage Stage IV - End of treatment	7 Participant	7 Participant	5 Participant	1 Participant	13 Participant	4 Participant	7 Participant	10 Participant	5 Participant	13 Participant	—	—
Changes in Fontaine Stage Missing - End of treatment	248 Participant	743 Participant	403 Participant	59 Participant	47 Participant	250 Participant	724 Participant	370 Participant	60 Participant	45 Participant	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.

Category 0 - Asymptomatic Category 1 - Mild claudication Category 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Category 3 - Severe claudication Category 4 - Rest pain Category 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 - Severe ischemic ulcers or frank gangrene

Outcome measures

Measure	Ticagrelor 90 mg bd n=1309 Participants	Clopidogrel 75 mg od n=3674 Participants	Ticagrelor - Stage IIb n=1620 Participants Baseline Fontaine stage IIb	Ticagrelor - Stage III n=186 Participants Baseline Fontaine stage III	Ticagrelor - Stage IV n=107 Participants Baseline Fontaine stage IV	Clopidogrel - Stage I n=33 Participants Baseline Fontaine stage I	Clopidogrel - Stage IIa n=1292 Participants Baseline Fontaine stage IIa	Clopidogrel - Stage IIb n=3736 Participants Baseline Fontaine stage IIb	Clopidogrel - Stage III n=1608 Participants Baseline Fontaine stage III	Clopidogrel - Stage IV n=192 Participants Baseline Fontaine stage IV	Clopidogrel - Cat 5 n=100 Participants Baseline Rutherford category 5	Clopidogrel - Cat 6 n=25 Participants Baseline Rutherford category 6
Changes in Rutherford Classification Category 1/2 - End of treatment	227 Participant	1948 Participant	560 Participant	41 Participant	23 Participant	5 Participant	230 Participant	1956 Participant	557 Participant	33 Participant	18 Participant	3 Participant
Changes in Rutherford Classification Missing - End of treatment	248 Participant	743 Participant	403 Participant	59 Participant	33 Participant	14 Participant	250 Participant	724 Participant	370 Participant	60 Participant	34 Participant	11 Participant
Changes in Rutherford Classification Category 0 - End of treatment	775 Participant	683 Participant	171 Participant	15 Participant	23 Participant	3 Participant	743 Participant	723 Participant	198 Participant	33 Participant	13 Participant	6 Participant
Changes in Rutherford Classification Category 3 - End of treatment	45 Participant	269 Participant	469 Participant	39 Participant	13 Participant	6 Participant	56 Participant	311 Participant	450 Participant	38 Participant	12 Participant	3 Participant
Changes in Rutherford Classification Category 4 - End of treatment	7 Participant	24 Participant	12 Participant	31 Participant	4 Participant	3 Participant	9 Participant	15 Participant	23 Participant	23 Participant	11 Participant	1 Participant
Changes in Rutherford Classification Category 5 - End of treatment	5 Participant	4 Participant	3 Participant	1 Participant	11 Participant	0 Participant	2 Participant	6 Participant	6 Participant	4 Participant	12 Participant	1 Participant
Changes in Rutherford Classification Category 6 - End of treatment	2 Participant	3 Participant	2 Participant	0 Participant	0 Participant	2 Participant	2 Participant	1 Participant	4 Participant	1 Participant	0 Participant	0 Participant

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Change in ankle brachial index (ABI) / toe brachial index (TBI).

Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):

Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4

Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:

Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg

Outcome measures

Measure	Ticagrelor 90 mg bd n=6908 Participants	Clopidogrel 75 mg od n=6940 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Change in ABI/TBI From Baseline ABI - 6 months N = 6184(Tica), 6319(Clopi)	0.016 Change in ABI/TBI Standard Deviation 0.136	0.011 Change in ABI/TBI Standard Deviation 0.134	—	—	—	—	—	—	—	—	—	—
Change in ABI/TBI From Baseline ABI - End of treatment N = 4951(Tica), 5073(Clopi)	0.022 Change in ABI/TBI Standard Deviation 0.167	0.016 Change in ABI/TBI Standard Deviation 0.167	—	—	—	—	—	—	—	—	—	—
Change in ABI/TBI From Baseline TBI - 6 months N = 55(Tica), 48(Clopi)	0.050 Change in ABI/TBI Standard Deviation 0.132	0.036 Change in ABI/TBI Standard Deviation 0.137	—	—	—	—	—	—	—	—	—	—
Change in ABI/TBI From Baseline TBI - End of treatment N = 36(Tica), 21(Clopi)	0.059 Change in ABI/TBI Standard Deviation 0.115	-0.065 Change in ABI/TBI Standard Deviation 0.304	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Any Amputation Caused by PAD	179 Participant	208 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Major Amputation Caused by PAD	100 Participant	116 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to PACD, an average of 2.5 years

Population: The population was the full analysis set, which included all randomized patients

Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6930 Participants	Clopidogrel 75 mg od n=6955 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
CV-related Hospitalization	1312 Participant	1314 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

Population: The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available

Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6910 Participants	Clopidogrel 75 mg od n=6932 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
TIMI Major Bleeding Events	113 Participant	109 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

Population: The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available

Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6910 Participants	Clopidogrel 75 mg od n=6932 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
TIMI Major or Minor Bleeding Events	193 Participant	175 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

Population: The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available

Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6910 Participants	Clopidogrel 75 mg od n=6932 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
PLATO Major Bleeding Events	206 Participant	188 Participant	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

Population: The population was the saftey analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available

Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

Outcome measures

Measure	Ticagrelor 90 mg bd n=6910 Participants	Clopidogrel 75 mg od n=6932 Participants	Ticagrelor - Stage IIb Baseline Fontaine stage IIb	Ticagrelor - Stage III Baseline Fontaine stage III	Ticagrelor - Stage IV Baseline Fontaine stage IV	Clopidogrel - Stage I Baseline Fontaine stage I	Clopidogrel - Stage IIa Baseline Fontaine stage IIa	Clopidogrel - Stage IIb Baseline Fontaine stage IIb	Clopidogrel - Stage III Baseline Fontaine stage III	Clopidogrel - Stage IV Baseline Fontaine stage IV	Clopidogrel - Cat 5 Baseline Rutherford category 5	Clopidogrel - Cat 6 Baseline Rutherford category 6
Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event	168 Participant	112 Participant	—	—	—	—	—	—	—	—	—	—

Adverse Events

Clopidogrel 75mg od

Serious events: 1788 serious events

Other events: 989 other events

Deaths: 0 deaths

Ticagrelor 90mg bd

Serious events: 1716 serious events

Other events: 1682 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clopidogrel 75mg od n=6932 participants at risk	Ticagrelor 90mg bd n=6910 participants at risk
Infections and infestations Liver abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Localised infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Lower respiratory tract infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Lung abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Lung infection	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.10% 7/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Lymphangitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Mediastinitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle cell sarcoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Anaemia	0.55% 38/6932 • Number of events 40 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.56% 39/6910 • Number of events 43 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Anaemia macrocytic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Anaemia of chronic disease	0.01% 1/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Aplastic anaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Autoimmune aplastic anaemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Haemorrhagic anaemia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Iron deficiency anaemia	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Lymphadenopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Microcytic anaemia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Neutropenia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Pancytopenia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Blood and lymphatic system disorders Thrombocytopenia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Angina pectoris	0.26% 18/6932 • Number of events 20 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.46% 32/6910 • Number of events 34 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Angina unstable	0.09% 6/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.14% 10/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Aortic valve disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Aortic valve incompetence	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Aortic valve stenosis	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Arrhythmia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Arrhythmia supraventricular	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Arteriosclerosis coronary artery	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Arteriospasm coronary	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrial fibrillation	0.97% 67/6932 • Number of events 69 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	1.00% 69/6910 • Number of events 69 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrial flutter	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrial tachycardia	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrioventricular block	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrioventricular block complete	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrioventricular block first degree	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Atrioventricular block second degree	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Bradyarrhythmia	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Bradycardia	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Bundle branch block left	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac arrest	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac failure	0.33% 23/6932 • Number of events 29 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.41% 28/6910 • Number of events 30 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac failure acute	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac failure chronic	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac failure congestive	1.3% 88/6932 • Number of events 108 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.98% 68/6910 • Number of events 81 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac tamponade	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardio-respiratory arrest	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiogenic shock	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiomyopathy	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiopulmonary failure	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Cardiovascular insufficiency	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Chronic left ventricular failure	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Congestive cardiomyopathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Coronary artery disease	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Coronary artery dissection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Heart valve stenosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Hypertensive heart disease	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ischaemic cardiomyopathy	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Left ventricular dysfunction	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Left ventricular failure	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Mitral valve incompetence	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Myocardial infarction	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Myocardial ischaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Nodal arrhythmia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Palpitations	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Pericardial effusion	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Sinus bradycardia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Sinus node dysfunction	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Sinus tachycardia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Stress cardiomyopathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Supraventricular extrasystoles	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Supraventricular tachycardia	0.06% 4/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Tachyarrhythmia	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Tachycardia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Tachycardia paroxysmal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Tricuspid valve incompetence	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ventricular arrhythmia	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ventricular extrasystoles	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ventricular fibrillation	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ventricular hypokinesia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Cardiac disorders Ventricular tachycardia	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.14% 10/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Congenital, familial and genetic disorders Arteriovenous malformation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Congenital, familial and genetic disorders Corneal dystrophy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Congenital, familial and genetic disorders Hydrocele	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Congenital, familial and genetic disorders Phimosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Acute vestibular syndrome	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Deafness	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Hypoacusis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Meniere's disease	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Middle ear effusion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Sudden hearing loss	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Tinnitus	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Vertigo	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Vertigo positional	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Ear and labyrinth disorders Vestibular disorder	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Adrenal insufficiency	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Goitre	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Hyperthyroidism	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Hypothyroidism	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Thyroid cyst	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Thyroid mass	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Endocrine disorders Thyroiditis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Angle closure glaucoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Cataract	0.20% 14/6932 • Number of events 17 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Conjunctival haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Diabetic retinopathy	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Exophthalmos	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Eye haemorrhage	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Macular hole	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Open angle glaucoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Optic ischaemic neuropathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Optic neuropathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Retinal artery embolism	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Retinal degeneration	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Retinal detachment	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Retinal haemorrhage	0.03% 2/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Retinal vein occlusion	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Retinoschisis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Uveitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Vision blurred	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Eye disorders Vitreous haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Abdominal adhesions	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Abdominal discomfort	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Abdominal hernia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Abdominal pain	0.13% 9/6932 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Abdominal pain upper	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Abdominal wall haematoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Acid peptic disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Acute abdomen	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Alcoholic pancreatitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Anal fistula	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Anal haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Anal incontinence	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Ascites	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Chronic gastritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Colitis	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Colitis ischaemic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Constipation	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Diarrhoea	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Diverticulum	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Diverticulum intestinal	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Duodenal polyp	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Duodenal ulcer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Duodenitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Dyspepsia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Dysphagia	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Enteritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Enterocolitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Enterocolitis haemorrhagic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Epigastric discomfort	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Erosive duodenitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Erosive oesophagitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Food poisoning	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastric disorder	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastric haemorrhage	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastric polyps	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastric ulcer	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastric ulcer haemorrhage	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastric ulcer perforation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastritis	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastritis alcoholic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastritis erosive	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastritis haemorrhagic	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastroduodenal ulcer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal angiodysplasia haemorrhagic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal haemorrhage	0.55% 38/6932 • Number of events 41 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.49% 34/6910 • Number of events 39 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Gastrooesophageal reflux disease	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Haematemesis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Haemorrhoids	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Hiatus hernia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Hypoaesthesia oral	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Ileus	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.14% 10/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Ileus paralytic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Impaired gastric emptying	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Incarcerated inguinal hernia	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Incarcerated umbilical hernia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Inguinal hernia	0.32% 22/6932 • Number of events 23 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.29% 20/6910 • Number of events 21 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Inguinal hernia strangulated	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intestinal haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intestinal infarction	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intestinal ischaemia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intestinal obstruction	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intestinal perforation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intestinal polyp	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Intra-abdominal haematoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Irritable bowel syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Large intestinal haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Large intestinal ulcer haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Large intestine perforation	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Large intestine polyp	0.22% 15/6932 • Number of events 16 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mallory-Weiss syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mechanical ileus	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Melaena	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mesenteric vein thrombosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Nausea	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oedematous pancreatitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophageal fistula	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophageal spasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophagitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophagitis haemorrhagic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Oesophagitis ulcerative	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatic cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatic mass	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatic pseudocyst	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatitis	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatitis acute	0.13% 9/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Pancreatitis relapsing	0.01% 1/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Peptic ulcer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Peptic ulcer haemorrhage	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Periodontal disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Proctitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Rectal haemorrhage	0.09% 6/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Rectal polyp	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Reflux gastritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Retroperitoneal haematoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Retroperitoneal haemorrhage	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Small intestinal haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Small intestinal obstruction	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Small intestinal perforation	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Small intestinal stenosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Strangulated umbilical hernia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Subileus	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Tongue dysplasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Umbilical hernia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Volvulus	0.01% 1/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Gastrointestinal disorders Vomiting	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Asthenia	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Chest discomfort	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Chest pain	0.10% 7/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Complication associated with device	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Complication of device removal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Cyst	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Death	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Drowning	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Face oedema	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Fatigue	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Gait disturbance	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders General physical health deterioration	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Generalised oedema	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Impaired healing	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Medical device site erosion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Multiple organ dysfunction syndrome	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Non-cardiac chest pain	0.53% 37/6932 • Number of events 38 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.54% 37/6910 • Number of events 40 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Oedema peripheral	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Pain	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Puncture site haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Pyrexia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Soft tissue inflammation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Strangulated hernia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Systemic inflammatory response syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Vascular stent occlusion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Vascular stent restenosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Vascular stent stenosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Vascular stent thrombosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
General disorders Vessel puncture site haematoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Bile duct obstruction	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Bile duct stenosis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Bile duct stone	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholangiolitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholangitis	0.04% 3/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholangitis acute	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholecystitis	0.12% 8/6932 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholecystitis acute	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholecystitis chronic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholelithiasis	0.19% 13/6932 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 16 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cholestasis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Fatty liver alcoholic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Gallbladder perforation	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Hepatic cirrhosis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Hepatic cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Hepatic haematoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Hepatitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Hepatitis acute	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Hepatobiliary disorders Liver injury	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Allergy to arthropod sting	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Allergy to chemicals	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Anaphylactic reaction	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Anaphylactic shock	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Drug hypersensitivity	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Hypersensitivity	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Immune system disorders Overlap syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abdominal abscess	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abdominal infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abdominal wall abscess	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abscess intestinal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abscess jaw	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abscess limb	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Abscess of salivary gland	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Acute hepatitis B	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Anal abscess	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Appendicitis	0.13% 9/6932 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Appendicitis perforated	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Arteriovenous graft site infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Arthritis bacterial	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Atypical mycobacterial pneumonia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Bacteraemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Bacterial infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Biliary tract infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Bone abscess	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Bronchitis	0.27% 19/6932 • Number of events 19 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.33% 23/6910 • Number of events 24 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Campylobacter gastroenteritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Carbuncle	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Cellulitis	0.38% 26/6932 • Number of events 28 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.39% 27/6910 • Number of events 28 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Cholangitis infective	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Cholecystitis infective	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Chronic hepatitis C	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Chronic sinusitis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Clostridium difficile colitis	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Clostridium difficile infection	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Colonic abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Corynebacterium bacteraemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Cystitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Device related infection	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Diabetic foot infection	0.03% 2/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Diabetic gangrene	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Diarrhoea infectious	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Diverticulitis	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Diverticulitis intestinal haemorrhagic	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Echinococciasis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Emphysematous cholecystitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Empyema	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Encephalitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Endocarditis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Endocarditis enterococcal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Epididymitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Epiglottitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Erysipelas	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Escherichia bacteraemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Escherichia infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Escherichia sepsis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Escherichia urinary tract infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Gallbladder abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Gallbladder empyema	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Gangrene	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Gastroenteritis	0.19% 13/6932 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Gastroenteritis salmonella	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Gastroenteritis viral	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Graft infection	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Groin abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Groin infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Haematoma infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Herpes virus infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Herpes zoster	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Impetigo	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Implant site infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Incision site infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Infected dermal cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Infected seroma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Infected skin ulcer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Infectious colitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Influenza	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Intervertebral discitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Kidney infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Klebsiella sepsis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Laryngitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Medical device site infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Meningitis tuberculous	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Muscle abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Mycobacterium avium complex infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Nasopharyngitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Necrotising fasciitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Oesophageal candidiasis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Ophthalmic herpes zoster	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Orchitis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Oropharyngeal candidiasis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Osteomyelitis	0.13% 9/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.10% 7/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Osteomyelitis chronic	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Paronychia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Periodontitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Peritonitis	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pneumonia	2.4% 164/6932 • Number of events 175 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	2.0% 137/6910 • Number of events 141 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pneumonia bacterial	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pneumonia influenzal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pneumonia klebsiella	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pneumonia pneumococcal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Post procedural cellulitis	0.01% 1/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Post procedural infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Postoperative abscess	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Postoperative wound infection	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pulmonary sepsis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pulmonary tuberculosis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pyelonephritis	0.06% 4/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pyelonephritis acute	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Pyelonephritis chronic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Rectal abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Respiratory tract infection	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Rotavirus infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Salmonellosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Scrotal abscess	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Sepsis	0.30% 21/6932 • Number of events 22 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.30% 21/6910 • Number of events 21 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Septic shock	0.19% 13/6932 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Sialoadenitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Soft tissue infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Splenic abscess	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Staphylococcal infection	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Staphylococcal sepsis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Streptococcal bacteraemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Subcutaneous abscess	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Subdiaphragmatic abscess	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Tetanus	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Tracheostomy infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Tuberculosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Tuberculous pleurisy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Upper respiratory tract infection	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Urethral stricture post infection	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Urinary tract infection	0.58% 40/6932 • Number of events 48 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.46% 32/6910 • Number of events 34 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Urinary tract infection bacterial	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Urinary tract infection fungal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Urosepsis	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.19% 13/6910 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Varicella zoster virus infection	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Vestibular neuronitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Viral infection	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Wound infection	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Infections and infestations Wound infection bacterial	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Acetabulum fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Anastomotic haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Anastomotic ulcer haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Ankle fracture	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Arthropod sting	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Avulsion fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Burns second degree	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Carotid artery restenosis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Chest injury	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Concussion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Contusion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Craniocerebral injury	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Fall	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Femoral neck fracture	0.16% 11/6932 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Femur fracture	0.19% 13/6932 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Fibula fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Foot fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Foreign body in eye	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Graft haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Head injury	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Heat illness	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Hip fracture	0.19% 13/6932 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Humerus fracture	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Hypobarism	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Incision site erythema	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Incisional hernia	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Joint dislocation	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Laceration	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Ligament sprain	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Limb injury	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Lower limb fracture	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Lumbosacral plexus injury	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Meniscus injury	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Multiple fractures	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Nerve injury	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Open globe injury	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Pelvic fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Periprosthetic fracture	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Pneumothorax traumatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Post concussion syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Post procedural complication	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Post procedural haemorrhage	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Postoperative ileus	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Procedural complication	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Procedural haemorrhage	0.16% 11/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Procedural hypotension	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Procedural nausea	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Pubis fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Radiation fibrosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Radius fracture	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Rib fracture	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Road traffic accident	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Scapula fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Seroma	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Skin injury	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Skin wound	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Skull fracture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Spinal compression fracture	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Spinal fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Subcutaneous haematoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Subdural haematoma	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Subdural haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Tendon rupture	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Thermal burn	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Tibia fracture	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Toxicity to various agents	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Traumatic fracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Vascular graft complication	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Wound	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Wound dehiscence	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Blood creatine phosphokinase MB increased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Blood creatinine increased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Blood glucose fluctuation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Blood urea increased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations C-reactive protein increased	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Computerised tomogram thorax abnormal	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Ejection fraction decreased	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Electrocardiogram ST segment depression	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Haemoglobin decreased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Haemoglobin increased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Hepatic enzyme increased	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Influenza A virus test positive	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Liver function test increased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Platelet count decreased	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Prostatic specific antigen increased	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Salmonella test positive	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Stool analysis abnormal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Investigations Thyroid function test abnormal	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Cachexia	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Dehydration	0.13% 9/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.14% 10/6910 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Diabetes mellitus	0.14% 10/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.26% 18/6932 • Number of events 22 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Diabetic ketoacidosis	0.04% 3/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Electrolyte imbalance	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Failure to thrive	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Gout	0.07% 5/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hypercalcaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	0.13% 9/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.22% 15/6910 • Number of events 16 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hyperkalaemia	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hyperosmolar hyperglycaemic state	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hypervolaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hypoglycaemia	0.17% 12/6932 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.25% 17/6910 • Number of events 18 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hypokalaemia	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Hyponatraemia	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Metabolic acidosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Metabolic disorder	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Metabolic syndrome	0.03% 2/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Shock hypoglycaemic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Arthritis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Arthropathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Back pain	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Bursitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Chondritis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Foot deformity	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Gouty arthritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.22% 15/6932 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Jaw cyst	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Muscle spasms	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Muscular weakness	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Myalgia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Osteoarthritis	0.59% 41/6932 • Number of events 45 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.58% 40/6910 • Number of events 41 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Osteolysis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Osteonecrosis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Periarthritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Soft tissue haemorrhage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.10% 7/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Spinal pain	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Synovial cyst	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Synovial disorder	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Systemic sclerosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.13% 9/6932 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of salivary gland	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal gland cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage IV	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign bone neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign laryngeal neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.17% 12/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage IV	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage III	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.04% 3/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage III	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disseminated large cell lymphoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer recurrent	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenocarcinoma	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gliomatosis cerebri	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangiopericytoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Huerthle cell carcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Insulinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular melanoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.16% 11/6932 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage III	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.14% 10/6932 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage 0	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.32% 22/6932 • Number of events 22 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.39% 27/6910 • Number of events 27 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage I	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage II	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant middle ear neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of eyelid	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of pleura	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal sinus cancer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nonkeratinising carcinoma of nasopharynx	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.27% 19/6932 • Number of events 19 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.22% 15/6910 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue cancer metastatic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter recurrent	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer stage 0	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Altered state of consciousness	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Amyotrophic lateral sclerosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Aphasia	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Basal ganglia infarction	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Brain injury	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Carotid artery aneurysm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Carotid artery disease	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Carotid artery occlusion	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Carotid artery stenosis	0.87% 60/6932 • Number of events 64 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.81% 56/6910 • Number of events 58 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Carpal tunnel syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cauda equina syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebellar haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebral atrophy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebral haemorrhage	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebral infarction	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebral ischaemia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebrovascular accident	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cerebrovascular insufficiency	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cervical myelopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cervicobrachial syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cognitive disorder	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Coma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Cranial nerve disorder	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Dementia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Depressed level of consciousness	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Diabetic coma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Diabetic neuropathy	0.06% 4/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Dizziness	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Drug withdrawal convulsions	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Dysaesthesia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Embolic stroke	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Encephalopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Epilepsy	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Facial paralysis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Guillain-Barre syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Haemorrhage intracranial	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Haemorrhagic cerebral infarction	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Haemorrhagic stroke	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Headache	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hemianopia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hemiparesis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hemiplegia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hydrocephalus	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hyperaesthesia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hypoglycaemic coma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hypoglycaemic seizure	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders IIIrd nerve paralysis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Internal carotid artery kinking	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Intracranial aneurysm	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Ischaemic stroke	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Lacunar infarction	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Loss of consciousness	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Lumbar radiculopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Lumbosacral plexopathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Metabolic encephalopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Monoplegia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Multiple sclerosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Multiple system atrophy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Myoclonus	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Nerve compression	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Nerve root compression	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Nervous system disorder	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Neuralgia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Paraesthesia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Paraparesis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Parkinsonism	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Partial seizures	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Polyneuropathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Post stroke epilepsy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Presyncope	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Radial nerve compression	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Radicular pain	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Radicular syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Radiculopathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Restless legs syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Ruptured cerebral aneurysm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Sciatica	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Seizure	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Sleep paralysis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Spinal cord compression	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Spondylitic myelopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Status epilepticus	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Subarachnoid haemorrhage	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Syncope	0.26% 18/6932 • Number of events 18 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.38% 26/6910 • Number of events 27 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Thalamus haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Toxic encephalopathy	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Transient global amnesia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Transient ischaemic attack	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Vascular dementia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Vertebrobasilar insufficiency	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Nervous system disorders Wernicke's encephalopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Product Issues Device dislocation	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Product Issues Device failure	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Product Issues Device leakage	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Product Issues Device malfunction	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Product Issues Device occlusion	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Affective disorder	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Agitation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Alcohol abuse	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Alcoholism	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Anxiety	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Anxiety disorder due to a general medical condition	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Cardiovascular somatic symptom disorder	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Completed suicide	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Delirium	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Depression	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Drug abuse	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Drug dependence	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Major depression	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Mental disorder due to a general medical condition	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Mental status changes	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Suicidal ideation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Psychiatric disorders Suicide attempt	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Acute kidney injury	0.46% 32/6932 • Number of events 32 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.69% 48/6910 • Number of events 52 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Acute prerenal failure	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Azotaemia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Bladder prolapse	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Calculus urinary	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Chronic kidney disease	0.19% 13/6932 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.29% 20/6910 • Number of events 23 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Diabetic nephropathy	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders End stage renal disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Haematuria	0.14% 10/6932 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Haemorrhage urinary tract	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Hydronephrosis	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Hypertensive nephropathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Nephritis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Nephrolithiasis	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Nephropathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Nephropathy toxic	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Nephrotic syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Perinephritis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Proteinuria	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal aneurysm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal arteriosclerosis	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal artery stenosis	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal atrophy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal colic	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal failure	0.27% 19/6932 • Number of events 19 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.20% 14/6910 • Number of events 14 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal impairment	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Renal tubular necrosis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Stress urinary incontinence	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Ureterolithiasis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urethral obstruction	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urethral stenosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urge incontinence	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urinary incontinence	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urinary retention	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urinary tract obstruction	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Renal and urinary disorders Urogenital haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Acquired phimosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Benign prostatic hyperplasia	0.19% 13/6932 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.14% 10/6910 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Breast enlargement	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Breast hyperplasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Breast mass	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Cystocele	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Epididymal cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Ovarian cyst	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Peyronie's disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Prostatitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Prostatomegaly	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Scrotal cyst	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Testicular atrophy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Uterine pain	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Uterine polyp	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Uterine prolapse	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Reproductive system and breast disorders Vulvovaginal pain	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.25% 17/6910 • Number of events 18 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Asphyxia	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Asthma	0.09% 6/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.0% 71/6932 • Number of events 100 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	1.3% 87/6910 • Number of events 113 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.06% 4/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.16% 11/6910 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Emphysema	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Epistaxis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Haemothorax	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal dysplasia	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Lung cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Mediastinal cyst	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Oropharyngeal spasm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pharyngeal stenosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.10% 7/6932 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pleurisy	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.09% 6/6932 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.12% 8/6910 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.22% 15/6932 • Number of events 15 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.26% 18/6910 • Number of events 18 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary hilum mass	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.09% 6/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.17% 12/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Decubitus ulcer	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Dermal cyst	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Dermatitis allergic	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Diabetic foot	0.12% 8/6932 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Drug eruption	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Eczema	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Hyperkeratosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Necrobiosis lipoidica diabeticorum	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Pemphigoid	0.01% 1/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Rash generalised	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Skin ulcer	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Skin ulcer haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Stasis dermatitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Subacute cutaneous lupus erythematosus	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Accelerated hypertension	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aneurysm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aneurysm ruptured	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aortic aneurysm	0.17% 12/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.13% 9/6910 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aortic aneurysm rupture	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aortic dissection	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aortic stenosis	0.17% 12/6932 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.10% 7/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aortic thrombosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Aorto-duodenal fistula	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Arteriosclerosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Arteriovenous fistula	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Behcet's syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Brachiocephalic artery stenosis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Deep vein thrombosis	0.16% 11/6932 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.17% 12/6910 • Number of events 12 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Extremity necrosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Femoral artery aneurysm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Haematoma	0.12% 8/6932 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Haemorrhage	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Hypertension	0.43% 30/6932 • Number of events 32 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.29% 20/6910 • Number of events 20 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Hypertensive crisis	0.13% 9/6932 • Number of events 9 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.14% 10/6910 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Hypertensive emergency	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Hypotension	0.06% 4/6932 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.07% 5/6910 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Hypovolaemic shock	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Iliac artery perforation	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Intermittent claudication	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Lymphatic fistula	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Lymphocele	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders May-Thurner syndrome	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Orthostatic hypotension	0.07% 5/6932 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.10% 7/6910 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Peripheral arterial occlusive disease	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Peripheral artery aneurysm	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Peripheral artery occlusion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Peripheral artery stenosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Peripheral embolism	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Phlebitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Phlebitis superficial	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Renovascular hypertension	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Shock	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Shock haemorrhagic	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Subclavian artery occlusion	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Subclavian artery stenosis	0.04% 3/6932 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.06% 4/6910 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Subclavian steal syndrome	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Temporal arteritis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.03% 2/6910 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Thromboangiitis obliterans	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Thrombophlebitis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Thrombophlebitis superficial	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Thrombosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Varicophlebitis	0.03% 2/6932 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Varicose vein	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Varicose vein ruptured	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Vasculitis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Vena cava thrombosis	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Venous perforation	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Venous thrombosis	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Venous thrombosis limb	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.04% 3/6910 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/6932 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.01% 1/6910 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer recurrent	0.01% 1/6932 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	0.00% 0/6910 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication

Other adverse events

Measure	Clopidogrel 75mg od n=6932 participants at risk	Ticagrelor 90mg bd n=6910 participants at risk
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 264/6932 • Number of events 289 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	11.8% 817/6910 • Number of events 968 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
Vascular disorders Haemorrhage	11.4% 787/6932 • Number of events 1078 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication	14.4% 997/6910 • Number of events 1451 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication

Additional Information

Brilinta Global Clinical Lead

AstraZeneca R&D

Phone: +46 31 776 10 00

Email: kontakt@astrazeneca.com

Results disclosure agreements

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